Scleral Buckling versus Primary Vitrectomy

in Rhegmatogenous Retinal Detachment

A Prospective Randomized Multicenter Clinical Study
Heinrich Heimann, MD,1 Karl Ulrich Bartz-Schmidt, MD,2 Norbert Bornfeld, MD,3 Claudia Weiss, MD,4
Ralf-Dieter Hilgers, PhD,4 Michael H. Foerster, MD,5 for the Scleral Buckling versus Primary Vitrectomy in
Rhegmatogenous Retinal Detachment Study Group*

Objective: To compare scleral buckling surgery (SB) and primary pars plana vitrectomy (PPV) in rhegmat-
ogenous retinal detachments of medium complexity.
Design: Prospective randomized multicenter clinical trial (the Scleral Buckling versus Primary Vitrectomy in
Rhegmatogenous Retinal Detachment Study), separated into phakic or aphakic/pseudophakic eyes. Patients
were enrolled over a 5-year period. There was 1-year follow up in the study, and the primary outcome was
assessed at 1 year.
Participants: Forty-five surgeons (25 centers, 5 European countries) recruited 416 phakic and 265 pseudopha-
kic patients. Completion of follow-up was achieved in 93% of the phakic and 89% of the pseudophakic patients.
Intervention: Scleral buckling surgery with the potential use of multiple sponges, encircling elements,
drainage, and intraocular injections. Primary vitrectomy included 3-port vitrectomy with sulfur hexafluoride–air
tamponade; additional SB was left to the surgeon’s decision.
Main Outcome Measures: Primary study end point: change in best-corrected visual acuity (BCVA); sec-
ondary end points: primary and final anatomical success, proliferative vitreoretinopathy, cataract progression,
and number of reoperations.
Results: In the phakic trial, the mean BCVA change was significantly (P ⫽ 0.0005) greater in the SB group
(SB, ⫺0.71 logarithm of the minimum angle of resolution [logMAR], standard deviation [SD] 0.68; PPV, ⫺0.56
logMAR, SD 0.76). In the pseudophakic trial, changes in BCVA showed a nonsignificant difference of 0.09
logMAR. In phakic patients, cataract progression was greater in the PPV group (P⬍0.00005). In the pseudopha-
kic group, the primary anatomical success rate (defined as retinal reattachment without any secondary retina-
affecting surgery; SB, 71/133 [53.4%]; PPV, 95/132 [72.0%]) was significantly better (P ⫽ 0.0020), and the mean
number of retina-affecting secondary surgeries (SB, 0.77, SD 1.08; PPV, 0.43, SD 0.85) was lower (P ⫽ 0.0032)
in the PPV group. Redetachment rates were 26.3% (SB; 55/209) and 25.1% (PPV; 52/207) in the phakic trial and
39.8% (SB; 53/133) and 20.4% (PPV; 27/132) in the pseudophakic trial.
Conclusions: The study shows a benefit of SB in phakic eyes with respect to BCVA improvement. No difference
in BCVA was demonstrated in the pseudophakic trial; based on a better anatomical outcome, we recommend PPV
in these patients. Ophthalmology 2007;114:2142–2154 © 2007 by the American Academy of Ophthalmology.

The treatment of rhegmatogenous retinal detachments important indications for vitreoretinal surgery, comprising
(RDs) and its complications continue to be one of the most about half of all surgical cases treated in vitreoretinal sur-

Originally received: December 21, 2006.

Final revision: August 17, 2007. Results presented at: Club Jules Gonin and Retina Society combined
Accepted: September 14, 2007. Manuscript no. 2006-1470. meeting, November 2006, Cape Town, South Africa.
1
St. Paul’s Eye Unit, Royal Liverpool University Hospital, Liverpool, The study was funded by grants from the German Research Foundation,
United Kingdom. Bonn, Germany (Fo 165/2 -1, -2, -3, -4; Le 842/3 -1, -2; Hi 541/2 -1, -2),
2
and “Stifterverband of German Science (Friedrich-Spicker-Stiftung),”
Universitäts-Augenklinik Tübingen, Tübingen, Germany. Wuppertal, Germany (no. S 050-10.003/004).
3
Universitäts-Augenklinik Essen, Essen, Germany. Correspondence and reprint requests to Heinrich Heimann, St. Paul’s Eye
4
Institut für Medizinische Statistik, Rheinisch-Westfälische Technische Unit, Royal Liverpool University Hospital, Prescot Street, Liverpool L7
Hochschule Aachen, Aachen, Germany. 8XP, United Kingdom. E-mail: heinrichheimann@yahoo.de.
5
Augenklinik, Campus Benjamin Franklin, Charité–Universitätsmedizin *See “Appendix 1” (available at http://aaojournal.org) for a list of the
Berlin, Berlin, Germany. Study Group’s active participants.

2142 © 2007 by the American Academy of Ophthalmology ISSN 0161-6420/07/$–see front matter
Published by Elsevier Inc. doi:10.1016/j.ophtha.2007.09.013
 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment
gery departments or practices.1 Different surgical methods
are available, and the choice of method, along with its
technical specifications, varies significantly between sur-
geons and centers. Overall, relatively high anatomical suc-
cess rates can be achieved with various techniques. How-
ever, all types of rhegmatogenous RD surgery are still
flawed by enduring shortcomings: about 40% of patients
will not achieve reading ability, about 10% to 40% will need
more than one surgical procedure (including additional reti-
nopexy or anterior segment surgery), and about 5% of eyes
will still have permanent anatomical and functional failure.2
Only a few studies comparing effects of different surgical
methods on these outcome variables have been conducted to
date.3–10
One of the areas in which further improvement might
be achieved is the adjustment of surgical methods to the
preoperative morphological situation, as initial clinical
presentations of rhegmatogenous RDs vary from rela-
tively uncomplicated cases with single breaks and only a
localized detachment to total detachments with multiple
breaks and preoperative proliferative vitreoretinopathy
(PVR). Most surgeons would adopt their choice of
method according to the anticipated level of difficulty of
the situation. In localized cases, pneumatic retinopexy
and scleral buckling surgery (SB) are the most popular
surgical methods. The recruitment study of the Scleral
Buckling versus Primary Vitrectomy in Rhegmatogenous
Retinal Detachment (SPR) Study examined a representa-
tive group of patients with rhegmatogenous RDs in par-
ticipating centers in the year 200011; about 50% of pa-
tients present with a localized detachment (up to 4 clock
hours) with single or neighboring breaks. In the partici-
pating centers, the vast majority of these cases were
treated with SB. At the other end of the spectrum, com-
plicated cases with PVR grade B or C, giant tears, or
macular holes comprise approximately 20% of all pri-
mary rhegmatogenous RDs and are most commonly
treated with primary pars plana vitrectomy (PPV).11 Be-
tween these two extremes, there is a large group of
rhegmatogenous RDs with medium severity that com-
prise about 30% of all primary rhegmatogenous RDs in
the SPR recruitment study.11 This group includes patients
with multiple breaks in different quadrants, bullous rheg-
matogenous RDs, breaks extending central to the equator,
breaks with marked vitreous traction, and rhegmatog-
enous RDs with unclear hole situations (no break, or not
all breaks could be identified on examination before
surgery) that are more common in pseudophakic rheg-
matogenous RDs. In these cases, SB and PPV or combi-
nations of both have been used, with a trend towards PPV
in recent years .2 A large debate about the optimal treat-
ment of these types of rhegmatogenous RD evolved, with
arguments for SB or PPV based mostly on results of
retrospective single-center studies.12,13 The SPR Study
was designed to compare SB and PPV in rhegmatogenous
RDs of medium complexity in a prospective randomized
multicenter trial to analyze the functional outcome of the
two surgical procedures.14
Materials and Methods
Trial Design
The trial design of the SPR Study has been reported.14 In brief, the
study was conducted as a randomized, controlled, prospective
multicenter clinical trial in which the two surgical procedures
(PPV and SB) were compared in two independent samples (par-
allel-group design). Based on the status of the lens (aphakic/
pseudophakic patients and phakic patients) the trial was divided
into two parallel separate trials within one setting. Institutional
review board/ethics committee approval was obtained at all par-
ticipating centers. The study is registered at the Freiburg Clinical
Trials Register (no. 000703; http://www.zks.uni-freiburg.de),
which meets the criteria of the International Committee of Medical
Journal Editors.15 Detailed information regarding sample size,
randomization, allocation concealment, blinding, statistical meth-
ods, participant flow, breach of study protocol, and adverse events
is available in “Appendix 2” (available at http://aaojournal.org).
Participants
Common inclusion criteria for both trials were primary rhegmat-
ogenous RDs with large breaks with a size between 1 and 2 clock
hours, multiple breaks, superior bullous detachment, central ex-
tension of breaks, or marked vitreous traction on the break. In
addition, patients with an unclear hole situation preoperatively
could be recruited for the aphakic/pseudophakic trial of the study
but not for the phakic trial. Unclear hole situations were defined as
either unseen breaks or the strong suspicion of additional but
unseen breaks that were not detected during the surgeon’s preop-
erative examination or using his or her clinical judgment. Exclu-
sion criteria for both trials were rhegmatogenous RDs that could be
treated with a single 7.5⫻2.75-mm radial episcleral sponge; breaks
posterior to the vessel arcades; PVR stage B or C; coexisting eye
diseases that have an impact on visual acuity (VA); previous
intraocular surgery, with the exception of uncomplicated cataract
surgery in the aphakic/pseudophakic trial; myopia of more than
⫺7.0 diopters; systemic disease that may influence the postoper-
ative course or wound healing; pregnancy; and age lower than 18
years. All study centers and surgeons received sample fundus
drawings of rhegmatogenous RDs representing characteristic in-
clusion and exclusion criteria for the study that were to be used
during the assessment of all patients with primary rhegmatogenous
RDs. These drawings have been published in a previous publica-
tion on the study design.14 The end point committee reviewed
eligibility of the patients to participate in the study with respect to
the inclusion and exclusion criteria in a masked fashion based on
preoperative fundus drawings and review of surgical notes.
Every patient gave written informed consent before participa-
tion in the study and agreed to be examined at 4 scheduled
follow-up visits: within the first week after surgery, 8 weeks after
surgery, 6 months after surgery, and 1 year after surgery. Addi-
tional examinations were performed in the case of reoperations or
at any unscheduled visit (e.g., because of concomitant therapy or
adverse events).
Interventions
Participating surgeons had to have performed 100 SB procedures
and 100 PPVs as primary surgeons before participation in the
study. Every participating surgeon explained his surgical proce-
dures, which were accepted by the steering committee if they were
in accordance with the study protocol. Patients with rhegmatog-
enous RD fulfilling the inclusion criteria were randomized to either
SB or PPV. For SB, silicone sponges and/or encircling bands were
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 Ophthalmology Volume 114, Number 12, December 2007
used according to the surgeons’ preferences. Retinopexy of breaks
was performed with cryopexy. Optional surgical steps included
intraocular injection of balanced saline solution, air, or sulfur
hexafluoride; external drainage of subretinal fluid (SRF); or para-
centesis.
Pars plana vitrectomy was performed as standard 3-port PPV
with a 20% to 40% sulfur hexafluoride–air mixture as endotam-
ponade and cryopexy or endolaser for retinopexy. Heavy liquids
and retinotomies for internal drainage were optional elements of
the surgical procedures. Due to feasibility considerations regarding
the sample size, there was no stratification or randomization for
additional SB in PPV. The use of additional SB in PPV was left to
the surgeon, who had to follow an approved procedure as de-
scribed above.
The necessity, timing, and choice of methods for revisional
surgery were based on clinical findings assessed by the study
surgeons (e.g., additional buckling surgery, intravitreal air injec-
tion, vitrectomy). In eyes with reoperations and silicone oil tam-
ponade, the protocol recommended but did not require removal of
the silicone oil before the final follow-up examination.
Objectives
The objective of the trial was to compare SB and PPV in rheg-
matogenous RDs of medium complexity in a prospective random-
ized multicenter trial to analyze the functional outcome, measured
as best-corrected VA (BCVA) of the two surgical procedures.
Additionally, anatomical outcomes (e.g., retinal reattachment) and
occurrence of PVR were evaluated. The intention of the trial was
to establish evidence-based recommendations for the treatment of
rhegmatogenous RDs of medium complexity.
Outcomes
The primary end point of the study was defined as the change in
BCVA (logarithm of the minimum angle of resolution [logMAR]
scale) from the initial examination to the 12-month visit using
letter-by-letter scoring on Early Treatment Diabetic Retinopathy
Study (ETDRS) charts.16 The analysis of the main end point was
carried out using the last observation carried forward (LOCF)
principle in cases of missing final BCVA. In cases of profound low
vision or near blindness, perception of counting fingers, hand
movements, light perception (LP), and no LP were substituted by
logMAR values of 1.7, 2.0, 2.5, and 3.0, respectively. In case of
missing ETDRS chart VA measurements, decimal VA values were
used and transferred to the logMAR scale.
The surgeons were advised to perform cataract surgery in
phakic patients within the follow-up period if they were of the
opinion that the developing cataract significantly interfered with
postoperative VA. If cataract surgery was scheduled at the time of
the last follow-up visit, the main end point, VA, had to be assessed
4 weeks after cataract surgery. If no cataract surgery was per-
formed despite clinically significant cataract development (defined
as an increase of ’2.0 units on the Lens Opacities Classification
System III [LOCS III] scale), the patient was excluded from the
analysis of the primary end point according to the protocol.17
The following criteria were defined as secondary end points:
1. Proliferative vitreoretinopathy rate. Postoperative occur-
rence of PVR grade B or C.
2. Primary anatomical success. Retinal reattachment was
defined as attachment of the retina central to the equator at
the final follow-up visit without any retina affecting the
procedure. Procedures considered to be retina affecting
were laser photocoagulation, cryopexy, intraocular gas in-
jection, SB or revisional SB, and vitrectomy or revisional
vitrectomy, including macular pucker surgery.
2144
3. Final anatomical success. Retinal reattachment at the final
follow-up visit, any kind of reoperation permitted.
4. Number of retina-affecting procedures.
5. Development of cataract in the phakic trial using the LOCS
III.17 Development of cataract was defined as an increase
of at least 1.0 on any of the LOCS III grading scales from
initial examination to visit 4.
The end point committee using photographic documentation
assessed endpoints 1,2, 3 and 5. Analysis of endpoints was carried
out within the full analysis set.
Results
Participant Flow
The patient flow is displayed in Figures 1 and 2. In the phakic trial,
7 patients did not receive the allocated treatment. In 6 patients, no
retinal reattachment could be achieved intraoperatively with SB
alone, and additional PPV was performed during the primary
intervention based on the surgeon’s decision. In 1 patient, SB was
performed incorrectly despite allocation of PPV as study treat-
ment.
In the pseudophakic/aphakic study arm, 9 patients did not
receive the allocated treatment. In 8 patients, no retinal reattach-
ment could be achieved intraoperatively with SB alone, and addi-
tional PPV was performed during the primary intervention. In 1
patient, SB was performed despite allocation of PPV as study
treatment due to unknown reasons.
Recruitment
Between August 1998 and June 2003, 45 surgeons in 25 centers of
5 European countries recruited 681 patients for the SPR Study
(416 for the phakic trial, 265 for the pseudophakic trial).
Median numbers of patients per surgeon were 6 (range, 1–36)
in the phakic trial and 4 (range, 1–28) in the pseudophakic trial.
Thus, in the phakic trial the median number of patients was 4
(range, 1–18) in the PPV group and SB group, and in the pseu-
dophakic trial, median numbers were 2 (range, 1–14) in the PPV
group and 3 (range, 1–14) in the SB group. The treatment alloca-
tion was balanced. We observed the largest difference in the
number of patients per treatment of 2 in 6% (2/35) of the surgeons
in the pseudophakic trial. Accordingly, in the phakic trial the
largest differences in the number of patients per treatment were 4
(1 surgeon) and 2 in 7% (3/41) of the surgeons. The difference was
at most 1 for all other surgeons.
Baseline Data
The baseline data regarding patient characteristics within treatment
groups and trials are listed in Table 1. The distributions are
balanced between the intervention groups in each trial. However,
the proportion of males is nearly 10% greater in the pseudophakic
group (SB group, 70.7%; PPV group, 75.0%) than in the phakic
group (SB group, 57.4%; PPV group, 61.4%), and the pseudopha-
kic patients tend to be slightly older.
Numbers Analyzed
In each trial, 2 randomization envelopes were opened erroneously,
and no patients were included in relation to these envelopes. The
full analysis set in the phakic trial consisted of 209 SB patients and
207 PPV patients. According to the protocol, VA measurements
that were significantly influenced by cataract development (defi-
 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment

Figure 1. Flow sheet of study progress—phakic patients. log MAR ⫽ logarithm of the minimum angle of resolution; n ⫽ no. of observations. *Surgeon’s
decision intraoperatively after randomization. †Wrong procedure performed intraoperatively due to unknown reasons. §Numbers include patients who were
excluded from analysis of the main end point, change in visual acuity (VA), because of cataract development (n ⫽ 14); patients for whom the final VA
was taken after the scheduled final follow-up visit because of cataract surgery at the time of the final follow-up visit (n ⫽ 10); and patients who missed
a final visit, for whom the end point was calculated by last-observation-carried-forward (n ⫽ 13). ¶Numbers include patients who were excluded from
analysis because of cataract (n ⫽ 33), patients for whom the final VA was taken after the scheduled final follow-up visit because of cataract surgery at
the time of the final follow-up visit (n ⫽ 24), and patients who missed a final visit, for whom the primary end point was calculated by last-observation-
carried-forward (n ⫽ 13).

nition above) had to be excluded for the analysis of the primary
end point in the phakic trial only. Thus, 14 SB and 33 PPV cases
were excluded, resulting in a full analysis set of 195 SB patients
and 174 PPV patients for the evaluation of the primary end point
only. In the pseudophakic trial, one case was excluded from the
analysis because the second eye of a patient was erroneously
randomized. Thus, the full analysis set in the phakic trial consisted
of 133 SB and 132 PPV patients. Note that the LOCF principle led
to a conservative estimate of treatment difference. The numbers of
cases in which final BCVA values were imputed by LOCF values
are given in Figures 1 and 2.
In some patients randomized to SB, no intraoperative reattach-
ment could be achieved, and based on intraoperative judgement, an
additional PPV was performed during the initial surgery (6 cases in
the phakic group, 8 cases in the pseudophakic/aphakic group). In
2 additional cases, the surgeon did not follow the randomization
for PPV but performed SB for unknown reasons. According to the
intention-to-treat principle, these cases were analyzed in relation to
the initially randomized procedure.
Duration of Follow-up and Major Outcomes
The mean follow-up periods in the phakic group were rather
balanced between the treatment groups (SB, 387.6 days [standard
deviation (SD), 180.6]; PPV, 410.5 days [SD, 217.4]). This applies

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 Ophthalmology Volume 114, Number 12, December 2007

Figure 2. Flow sheet of study progress—pseudophakic patients. log MAR ⫽ logarithm of the minimum angle of resolution; n ⫽ no. of observations.
*Surgeon’s decision intraoperatively after randomization. †One patient excluded from analysis because of incorrect inclusion of a fellow eye in a patient
who had already been included in the study with the first eye. §Numbers include patients who missed a final visit, for whom the end point was calculated
by last-observation-carried-forward (n ⫽ 9). ¶Numbers include patients who missed a final visit, for whom the primary end point was calculated by
last-observation-carried-forward (n ⫽ 21).

also to the pseudophakic trial (SB, 372.5 days [SD, 103.1]; PPV,
352.1 days [SD, 136.3]).
The results of the primary and secondary end points for both
study groups are given in Tables 2 and 3.
Results of the Phakic Subtrial
In the phakic subtrial, BCVA measurements of 195 SB and 174
PPV patients were used in the analysis. In 39 of the SB cases and
in 51 PPV cases, BCVA was measured using decimal VA reading
charts instead of ETDRS charts. These values were transferred to
logMAR VA values.
The BCVA after 1 year compared with the baseline value (Fig
3 [available at http://aaojournal.org]) shows a mean improvement
in the SB group (⫺0.71; SD, 0.68; 95% confidence interval [CI],
⫺0.81 to ⫺0.62) as well as in the PPV group (⫺0.56; SD, 0.76;
95% CI, ⫺0.68 to ⫺0.45). The mean BCVA change between the
treatment groups was 0.15 (95% CI, 0.00 – 0.29). According to the
protocol, we fitted a 2-factor analysis of variance (ANOVA) model
to the data of the BCVA change. The model explained only 14%
of the total variation in the data (in terms of R2), suggesting a poor
fit of the model. Further, as can be seen in Table 2, final BCVA
increases almost by the same amount between the treatment groups
compared with baseline BCVA. Therefore, we included baseline
BCVA as a covariable in the ANOVA model, resulting in an R2 ⫽
72% explanation of the total variation in the data. The correspond-
ing F test of the analysis of covariance model (SAS [SAS Inc.,
Cary, NC] type II, proc GLM, stratified by surgeon) yielded a P
value of 0.0004 (F1,324 [observed value of the F statistic] ⫽ 12.78)
and showed a significant difference at the preplanned 5% level.
The treatment-by-surgeon interaction gives no signs for a de-
pendence of the BCVA difference between treatments across sur-

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 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment

Table 1. Patient Baseline Characteristics

Phakic Patients Pseudophakic Patients

SB (n ⫽ 209) PPV (n ⫽ 207) SB (n ⫽ 133) PPV (n ⫽ 132)
Male [n (%)] 120 (57.4) 127 (61.4) 94 (70.7) 99 (75.0)
Age (yrs) [mean (SD)] 61.3 (11.1) 59.7 (10.5) 66.4 (10.4) 64.6 (10.5)
Height (cm) [mean (SD)] 172.7 (9.2) 173.0 (9.0) 173.7 (9.2) 174.0 (8.4)
Weight (kg) [mean (SD)] 79.8 (14.6) 80.6 (16.3) 79.9 (12.6) 81.5 (12.8)
Macula-off detachment (%) 132 (63.2) 130 (62.8) 89 (66.9) 82 (62.1)
Intraocular pressure (mmHg) [mean (SD)] 14.6 (3.7) 14.5 (3.1) 14.3 (4.1) 14.6 (3.4)
Spherical equivalent (D) [mean (SD)] ⫺1.10 (2.68) ⫺0.98 (2.80) ⫺0.54 (2.44) ⫺0.54 (2.27)
Astigmatism (D) [mean (SD)] ⫺0.67 (0.92) ⫺0.70 (1.01) ⫺0.95 (1.03) ⫺0.84 (0.93)

n ⫽ no. of observations; PPV ⫽ primary pars plana vitrectomy; SB ⫽ scleral buckling surgery; SD ⫽ standard deviation.

geons (F21,324 ⫽ 0.92, P ⫽ 0.5644). The F test for the covariable
resulted in P⬍0.00005 (F1,324 ⫽ 684.02). Further, the F test for
surgeon (F21,324 ⫽ 0.80, P ⫽ 0.7235) does not indicate differences
in the BCVA change correlated to the surgeon. Moreover, the
conclusions above do not depend on the exclusion of the cataract
cases from the analysis or the imputation of BCVA measurement
according to the LOCF principle or a not-in-hospital measurement
of BCVA, as was found by sensitivity analysis.
Postoperative rates of PVR grade B or C were 12.4% (26/209)
(95% CI, 8.3%–17.7%) in the SB group and 16.4% (34/207) (95%
CI, 11.7%–22.2%) in the PPV group. The stratified odds ratio
(OR) between the SB group and PPV group was 0.75 (95% CI,
0.44 –1.28). The Mantel–Haenszel chi-square tests stratified by
surgeon (SAS, proc freq) yielded a P value of 0.2812. The
Breslow–Day test (SAS, proc phreg) for homogeneity of the ORs
did not indicate an interaction (P ⫽ 0.0856).
Primary anatomical success, defined as retinal reattachment
without any secondary vitreoretinal surgery including retinopexy
or intraocular injections, was reached in 63.6% (133/209) (95% CI,
56.7%–70.2%) in the SB group and 63.8% (132/207) (95% CI,
56.8%–70.3%) in the PPV group. The stratified OR between the
SB group and PPV group was 1.01 (95% CI, 0.68 –1.49). The
Mantel–Haenszel chi-square tests stratified by surgeon (SAS, proc
freq) yields a nonsignificant P value of 0.9709. The definition of
primary anatomical success usually entails retinal redetachments
that necessitate only major surgery. Cases of prophylactic reti-
nopexy or minor corrections (e.g., secondary injection of a gas
bubble, minor revisions of the scleral buckle) are usually not
included. Our definition of primary success might thus be mistaken
for retinal redetachment. Therefore, we also include values for
retinal redetachment for illustration purposes (Table 2). Retinal
redetachments were seen in 26.3% (55/209) in the SB group and
25.1% (52/207) in the PPV group. In 4 phakic patients, no retina-
affecting reoperation was documented despite retinal redetachment
during follow-up. In one of these cases, no reoperation was per-
formed for unknown reasons; in 3 patients, no details about retinal
attachment could be determined at the 12-month examination, and
in such cases, a worst case scenario (e.g., retinal redetachment)
was recorded.
Final anatomical success was achieved in 96.7% (202/209)
(95% CI, 92.0%–98.0%) in the SB group and 96.6% (200/207)
(95% CI, 93.2%–98.6%) in the PPV group. The stratified OR
between the SB group and PPV group was 1.07 (95% CI, 0.35–
3.25). The Mantel–Haenszel chi-square tests stratified by surgeon
(SAS, proc freq) yield a nonsignificant P value of 0.9003.
The mean numbers of retina-affecting procedures were 0.63
(SD, 1.02; 95% CI, 0.49 – 0.77) in the SB group and 0.51 (SD,
0.85; 95% CI, 0.39 – 0.62) in the PPV group. In other words, it can
be stated that in both groups nearly 65% of the patients had no
secondary intervention during follow-up; in the remaining 35%,
between 1 and 6 additional procedures were performed. We used
van Elteren’s version of a stratified Wilcoxon rank sum test (strat-
ification according to surgeon) resulting in (df, 5; score, 16.03) a P
value of 0.0136, which is below the prespecified significance level

Table 2. Analysis of the Primary and Secondary End Points in the Phakic Trial (95% Confidence Interval [CI] for the Difference
and P Value from the Analysis of Covariance Model and Mantel–Haenszel Chi-Square Tests)

SB (n ⴝ 209) PPV (n ⴝ 207)

Treatment Difference
Characteristic Baseline Final Baseline Final (95% CI) P Value
BCVA (logMAR) [mean (SD)] 1.04 (0.74) 0.33 (0.35) 1.05 (0.79) 0.48 (0.51) 0.15 (0.00–0.29) 0.0005
Postoperative PVR [n (%)] — 26 (12.4) — 34 (16.4) 4.0% (⫺2.8 to 10.7) 0.2812
Retinal redetachment* [n (%)] 55 (26.32) 52 (25.12)
Primary anatomical success† [n (%)] — 133 (63.6) — 132 (63.8) 1.01% (0.68–1.49) 0.9709
Final anatomical success [n (%)] — 202 (96.7) — 200 (96.6) 1.07% (0.35–3.25) 0.9003
Retina-affecting procedures [n (SD)] — 0.63 (1.02) — 0.51 (0.85) 0.12 (⫺0.30 to 0.05) 0.1713
Cataract progression‡ [n (%)] — 96 (45.9) — 160 (77.3) 31.4% (22.5–40.2) ⬍0.00005

BCVA ⫽ best-corrected visual acuity; logMAR ⫽ logarithm of the minimum angle of resolution; PPV ⫽ primary pars plana vitrectomy; PVR ⫽
proliferative vitreoretinopathy; SB ⫽ scleral buckling surgery; SD ⫽ standard deviation.
*Not defined as a secondary end point; therefore, no statistical analysis was performed in the main analysis. This value is presented for illustration purposes,
as our definition of primary anatomical success, which is broader, might be mistaken for retinal redetachment.
†
Retinal reattachment without a retina-affecting reoperation including retinopexy (see text for details).
‡
A ⬎1.0 increase in one of the Lens Opacities Classification System III gradings.

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Table 3. Analysis of the Primary and Secondary End Points in the Pseudophakic/Aphakic Trial (95% Confidence Interval [CI] for
the Difference and P Value from the Analysis of Covariance Model and Mantel–Haenszel Chi-Square Tests)

SB (n ⴝ 133) PPV (n ⴝ 132)

Treatment Difference
Characteristic Baseline Final Baseline Final (95% CI) P Value
BCVA (logMAR) [mean (SD)] 1.02 (0.69) 0.46 (0.51) 1.02 (0.74) 0.38 (0.48) 0.09 (⫺0.02 to 0.2) 0.1033
Postoperative PVR [n (%)] — 30 (22.6) — 20 (15.2) 18.6% (7.2–30.0) 0.1073
Retinal redetachment* [n (%)] 53 (39.85) 27 (20.45)
Primary anatomical success† [n (%)] — 71 (53.4) — 95 (72.0) 18.6% (⫺7.2 to 30.0) 0.0020
Final anatomical success [n (%)] — 124 (93.2) — 126 (95.5) 2.2% (⫺7.8 to 3.3) 0.9686
Retina-affecting procedures [n (SD)] — 0.77 (1.08); CI, 0.59–0.69 — 0.43 (0.85); CI, 0.29–0.58 0.34 (⫺0.12 to 0.57) 0.0032

BCVA ⫽ best-corrected visual acuity; logMAR ⫽ logarithm of the minimum angle of resolution; PPV ⫽ primary pars plana vitrectomy; PVR ⫽
proliferative vitreoretinopathy; SB ⫽ scleral buckling surgery; SD ⫽ standard deviation.
*Not defined as a secondary end point, therefore no statistical analysis was performed in the main analysis; this value is presented for illustration purposes
as our definition of primary anatomical success, which has a broader definition, might be mistaken for retinal redetachment.
†
Retinal reattachment without retina-affecting reoperation including retinopexy (see text for details).

of 5%. Silicone oil was used as a tamponade during revisional
surgery in 19 of 209 patients of the SB group (9.1%); in 10 of these
patients, the silicone oil was removed before the final follow-up
examination and was still in place in the remaining 9 patients. In
the PPV group, silicone oil was used in 37 of 207 patients (17.9%).
The oil was removed in 21 of these patients and still in situ in 16
patients.
A development or progression of cataract, defined as an in-
crease of ⱖ1.0 in 1 of the 4 gradings of the LOCS III, could be
documented in 45.9% of patients (96/209) (95% CI,
39.0%–52.9%) in the SB group and in 77.3% (160/207) (95% CI,
71.0%– 82.8%) in the PPV group. The stratified OR between the
SB group and PPV group was 3.83 (95% CI, 2.51–5.86). The
Mantel–Haenszel chi-square tests stratified by surgeon (SAS, proc
freq) yielded a significant P value of ⬍0.00005.
The Breslow–Day test (SAS, proc phreg) for homogeneity of
the ORs did not indicate an interaction in this case (P ⫽ 0.0668).
Based on our experiences during running of the trial, an increase
of LOCS III of 2.0 units was more reliable to define cataract
development than an increase of 1.0. Thus, we also defined cata-
ract development by an increased LOCS III of 2.0. With this
definition, the difference in the proportions, with 6.7% (95% CI,
3.7%–11.0%) in the SB group versus 15.9% (95% CI, 11.2%–
21.7%) in the PPV group were less extreme. The corresponding
Mantel–Haenszel chi-square tests stratified by surgeon (SAS, proc
freq) yielded a significant P value of 0.0039.
Results of the Pseudophakic/Aphakic Trial
The BCVA after 1 year compared with the baseline value (Fig 4
[available at http://aaojournal.org]) shows a clear mean improve-
ment of ⫺0.56 (SD, 0.78; 95% CI, ⫺0.69 to ⫺0.42) in the SB
group as well as in the PPV group, with ⫺0.65 (SD, 0.69; 95% CI,
⫺0.76 to ⫺0.53). The mean BCVA change between the treatment
groups was about 0.09 (95% CI, ⫺0.02 to 0.20). The preplanned
ANOVA model fitted only fairly to the data (R2 ⫽ 20%) and could
be improved upon (R2 ⫽ 66%) by inclusion of the baseline BCVA
as a covariable in the model.
The corresponding F test of the analysis of covariance model
(SAS type II, proc GLM, stratified by surgeon) yielded a P value
of 0.1033 (F1,221 ⫽ 2.68) and failed to show significance at the 5%
level. The treatment-by-surgeon interaction gives no evidence for
a dependence of the BCVA difference between treatments from
surgeons (F20,221 ⫽ 0.57, P ⫽ 0.9328). Similarly, the F test for
surgeons fails to show significant differences (F21,221 ⫽ 1.50, P ⫽
0.0785). Further, the conclusions above do not depend on impu-
tation of BCVA measurement according to the LOCF principle or
a not-in-hospital measurement of the BCVA, as was found by
sensitivity analysis.
Rates of postoperative PVR grade B or C were 22.6% (30/133)
(95% CI, 15.8%–30.6%) in the SB group and 15.2% (20/132)
(95% CI, 9.5%–22.4%) in the PPV group. The stratified OR
between the SB group and PPV group was 1.67 (95% CI, 0.89 –
3.11). The Mantel–Haenszel chi-square tests stratified by surgeon
(SAS, proc freq) yielded a nonsignificant P value of 0.1073. The
Breslow–Day test (SAS, proc phreg) for homogeneity of the ORs
did not indicate an interaction in this case (P ⫽ 0.2384).
Primary anatomical success was reached in 53.4% (71/133)
(95% CI, 44.5%– 62.1%) in the SB group and 72.0% (95/132)
(95% CI, 63.5%–79.4%) in the PPV group. The stratified OR
between the SB group and PPV group was 0.44 (95% CI, 0.26 –
0.75). The Mantel–Haenszel chi-square tests stratified by surgeon
(SAS, proc freq) show significantly better success rates without
retina affecting reoperations for the PPV group at the preplanned
5% level (P ⫽ 0.0020). The Breslow–Day test (SAS, proc phreg)
for homogeneity of the ORs did not indicate an interaction in this
case (P ⫽ 0.4387, 2 sided). Retinal redetachment was seen in
39.9% (53/133) in the SB group and 20.5% (27/132) in the PPV
group. In 4 pseudophakic patients, no retina-affecting reoperation
was documented during follow-up. In one of these cases, there was
only a peripheral redetachment, and the study surgeon decided that
no surgical intervention was necessary; in 1 patient, the reopera-
tion was performed after completion of the 12-month follow-up
period; in 2 patients, no details about retinal attachment could be
determined at the 12-month examination, and in such cases, a
worst case scenario (e.g., retinal redetachment) was recorded.
Final anatomical success was achieved in 93.2% (124/133)
(95% CI, 87.5%–96.9%) in the SB group and 95.5% (126/132)
(95% CI, 90.4%–98.3%) in the PPV group. The stratified OR
between the SB group and PPV group was 0.62 (95% CI, 0.21–
1.86). The Mantel–Haenszel chi-square tests stratified by surgeon
(SAS, proc freq) showed no different redetachment rates at the end
of the follow-up period at the 5% level (P ⫽ 0.3999).
The mean numbers of retina-affecting procedures were 0.77 in
the SB group (SD, 1.08; 95% CI, 0.59 – 0.96) and 0.43 in the PPV
group (SD, 0.85; 95% CI, 0.29 – 0.58). In other words, it can be
stated that nearly 55% (73/133) of the SB patients and 73%
(97/132) of the PPV patients were not reoperated at all and that, in
the remaining patients, between 1 and 5 reoperations had to be
performed. We used van Elteren’s version of a stratified Wilcoxon
rank sum test (stratification according to surgeon) resulting in
significant different numbers of reoperations (df, 5; score, 12.67; P

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 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment
⫽ 0.0266). Silicone oil was used as a tamponade during revisional
surgery in 29 of 133 patients (21.8%) of the SB group; in 10 of
these patients, the silicone oil was removed before the final fol-
low-up examination and was still in place in 16 patients. No details
regarding silicone oil status at final follow-up were available in 3
of these 29 patients. In the PPV group, silicone oil was used in 15
of 133 patients (11.3%). In 9 patients, it was removed during
follow-up and still in situ in 6 patients at the final examination.
Interpretation for the Phakic Trial
In both treatment groups, BCVA significantly improved after 1
year compared with the preoperative BCVA. The improvement in
the SB group (mean, 7 lines), however, was significantly greater
than that in the PPV group (mean, 5 lines). Proliferative vitreo-
retinopathy grade B or C occurred in both treatment groups in 12%
to 16% of patients. The primary anatomical success (retinal at-
tachment without any retina-affecting intervention within the
1-year follow-up period) was achieved in both treatment groups in
nearly 60% of patients. No significant differences could be seen in
the anatomical success rated between the groups. Similarly, overall
successes were comparable in both treatment groups, with around
95% of retinal reattachment at the final follow-up examination.
Our data show that numbers of retina-affecting reoperations were
comparable in both treatment groups, with 65% of patients not
receiving any secondary surgery. It has to be noted that our
definition of primary success and retina-affecting secondary sur-
gery are subject to bias depending on the treating surgeon. This is
because the judgment about the need for secondary surgery varies
between different surgeons (e.g., laser retinopexy vs. observation
in suspicious retinal areas or secondary intravitreal injection of gas
vs. observation in cases of SB with persistence of SRF postoper-
atively). We observed that mean numbers of procedures vary
between surgeons without developing a clear trend (range, 0.20 –
1.13). However, as this is an open-label trial the differences in
numbers of reoperations between the treatment groups vary mark-
edly (range, ⫺1.5 to 1.5) depending on the surgeon’s decision,
which may be biased by unblinding of the surgeon. In conclusion,
no definite advantage of one of the two methods could be found
regarding the anatomical outcome. Development of cataract is
known to be correlated with PPV and could be demonstrated in
this trial using the LOCS III. Thus, the findings of a significantly
greater cataract rate after PPV compared with the SB rate is
substantiated by our data.
Interpretation for the Pseudophakic/Aphakic Trial
The BCVA was significantly improved after 1 year compared with
preoperative BCVA in both treatment groups, without significant
differences being observed between them. The rates of PVR grade
B or C were similar in both treatment groups, at 15% to 23% of
cases. Nearly half of the patients initially treated with SB achieved
complete retinal attachment without any reoperation within that
year. In the PPV group, this success rate was significantly greater,
as evidenced by a redetachment rate of 20.45% in the PPV group
versus 39.85% in the SB group. Almost all patients achieved
complete retinal attachment after 1 year with or without additional
surgery. No difference was observed between the treatment groups
regarding final reattachment; this was achieved in close to 95% of
all patients in both groups. Because of a greater primary success
rate and fewer retina-affecting reoperations, the anatomical results
of PPV seem to be superior to those of SB in the pseudophakic/
aphakic group of this trial.
Ancillary Analyses
According to the study protocol, cataract surgery was recom-
mended during follow-up in the phakic trial if it was judged to
improve VA significantly. The rate of cataract surgeries during or
at the end of the follow-up period was greater in the PPV group
(58.0% [120/207]) than in the SB group (20.6% [43/209]), with a
significant difference of 37.4% (95% CI, 28.7%– 46.1%).
The combination of PPV with an additional scleral buckling
element (e.g., encircling band, single sponge) was not randomized
for reasons stated above. Therefore, no data based on a randomized
comparison regarding this important issue are available from our
study. To detect if differences between patients operated on with
PPV with an additional buckle and those with PPV without an
additional buckle could be noted, however, we pooled the data of
the PPV groups of both trials and analyzed them with respect to
PVR development and retinal redetachment. First, our data show
that the application of additional buckling in the PPV group
correlated greatly with the lens status of the patients, with greater
rates in pseudophakic patients. An additional buckle was used in
66.7% (88/132) of the pseudophakic patients and in 50.7% (105/
207) of the phakic patients. We then fitted a logistic regression
model (with the factors additional buckle, trial, and interaction) to
the data of PVR development and found that there is no difference
for the use of an additional buckle alone (P ⫽ 0.9856). Only the
interaction effect reaches the statistical significance level (P ⫽
0.0082). The PVR rates do not differ in the pseudophakic patients,
where 11.4% (10/88) with an additional buckle, compared with
22.7% (10/44) without a buckle, showed PVR grade B or C
(difference, 11.4%; 95% CI, ⫺2.7 to 25.4). In contrast, 21.9%
(23/105) of phakic patients with an additional buckle compared
with 10.8% (11/102) of those without a buckle showed PVR grade
B or C (difference, 11.1%; 95% CI, 1.2%–21.1%).
The same evaluation regarding redetachment rates leads to
significantly different rates with respect to the factor additional
buckle (P ⫽ 0.0309) alone and interacting with trial (P ⫽ 0.0001).
When looking at the interaction effect, the redetachment rates do
not differ in the phakic patients, with 29.5% (31/105) with an
additional buckle, compared with 20.6% (21/102) without a
buckle, resulting in a rate difference of 8.9% (95% CI, ⫺2.8% to
20.7%). In the pseudophakic patients, however, 11.4% (10/88) of
the patients with an additional buckle compared with 40.9% (18/
44) without a buckle showed a redetachment, resulting in a rate
difference of 29.6% (95% CI, 13.6%– 45.5%).
Interpretation of the Ancillary Analysis
The greater rate of cataract formation in the PPV group of the
phakic trial translates to a greater rate of cataract surgery and is a
clear disadvantage of PPV in this group. The results of the analysis
regarding additional scleral buckling in the PPV group have to be
interpreted with caution due to the reasons stated above. However,
from the available data, additional buckling does not seem to
increase the success rates in phakic patients but might be associ-
ated with a greater rate of postoperative PVR grade B or C. In
contrast, anatomical results were significantly better in pseudopha-
kic/aphakic patients operated on with an additional buckle.
Breach of Study Protocols
To detect a possible breach of inclusion criteria and protocol
violations, the end point committee reviewed medical histories,
preoperative fundus drawings, clinical data, and surgical notes of
all cases. Overall, 37 cases with one or more violations were
detected in the phakic trial and 30 in the pseudo/aphakic trial
(Table 4 [available at http://aaojournal.org]). All cases were ana-
lyzed according to the intention-to-treat method.
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Table 5. Studies Comparing Scleral Buckling Surgery (SB) and Primary

Author Design Lens Status Inclusion Criteria Follow-up (mos) n

Oshima (2000) 7
Retrospective, 2 centers Phakic, pseudopahkic Macula off ⱖ24 55
Miki (2001)6 Retrospective, single center Phakic Superior detachment with flap tears ⱖ6 138
Roider (2001)8 Retrospective, single center Phakic, pseudophakic Large and multiple breaks 9 (mean) 60
Le Rouic (2002)22 Retrospective, single center Pseudophakic Rhegmatogenous RD in ⱖ6 40
pseudophakic patients
Tewari (2003)10 Prospective, randomized, Phakic, pseudophakic, Unseen breaks 3 20
single center aphakic
Afrashi (2004)3 Retrospective, single center Phakic, pseudophakic Multiple breaks ⱖ6 30
Sharma (2005)9 Prospective, randomized, Pseudophakic Macula off 6 25
single center
Ahmadieh (2005)4 Prospective, randomized, Pseudophakic, Macula off (PVR grade B) 6 125
multicenter aphakic
Brazitikos (2005)5 Prospective, single center Pseudophakic PVR grade B or less 12 75

logMAR ⫽ logarithm of the minimum angle of resolution; n ⫽ no. of observations.

All numbers were rounded by 2 decimal digits for presentation.

In a total of 28 patients, the morphological characteristics of the
RD did not fulfill the SPR inclusion criteria. These cases included
“single sponge possible” situations, preoperative PVR grade B or
C, breaks at the posterior pole, preoperative macular pucker,
unclear hole situation in a phakic patient, and RD associated with
retinoschisis. In 5 cases, significant concomitant eye diseases
judged to influence BCVA were noted (retinoschisis, amblyopia,
retinal vein occlusion, macular pucker, and recurrent uveitis). In 10
patients, review of the medical history revealed the presence of
exclusion criteria (history of ocular trauma, warfarin treatment,
severe asthma and hypertension, and participation in other clinical
trials).
After reviewing the surgical notes, several protocol violations
were noted. In 6 phakic and 8 pseudophakic patients, the retina
could not be successfully reattached intraoperatively with the
randomized SB procedure (according to judgment of the study
surgeon); in these cases, an additional PPV was performed during
the primary surgical intervention. In 1 patient in the phakic sub-
group and 1 patient in the pseudophakic subgroup, an SB proce-
dure without PPV was performed despite randomization to PPV
surgery. In 5 patients of the phakic subgroup, PPV was combined
with cataract surgery against the study guidelines. In 10 patients of
the phakic subgroup and 5 patients of the pseudophakic subgroup,
intraocular tamponades other than the predefined sulfur hexafluo-
ride–air mixtures were used (perfluoropropane–air, hexafluoretha-
ne–air, and 5000-centistoke silicone). Regarding the numbers
within the subgroups, the breach of inclusion criteria did not
appear to affect one of the subgroups compared with the entire
group of patients or significantly influence the results in favor of
one over the other surgical technique.
Adverse Events
Five patients died during the follow-up period (3 SB, 2 PPV) with
no relation to the surgical procedure. One eye in the SB group of
pseudophakic patients was enucleated during follow-up because of
unsuccessful reattachment surgery and a painful eye. The VA of
these patients was substituted by the worst case (logMAR 3.0).
Discussion
The surgical treatment of rhegmatogenous RD remains a
highly individual matter that is influenced by the preopera-
tive findings, patient characteristics, available tools for sur-
gery, and experience and ability of the operating surgeon.
One major factor that determines the outcome of the surgery
is the choice of operating method. A wide variety and
combinations of different techniques are available, but there
is little evidence-based data available regarding the efficacy
of different surgical procedures. In recent years, a shift in
the choice of methods can be observed, with a definite trend
towards PPV. This is caused by an increase in the number
of indications for PPV, numerous studies with excellent
results in the treatment of complex rhegmatogenous RD,
and proposed advantages of PPV over SB (e.g., improved
internal search for breaks, elimination of vitreous traction,
removal of the vitreous as a PVR-stimulating environ-
ment).2,18 However, a definite advantage of PPV over SB in
these situations has never been proven. Some authorities
warn that the trend towards PPV is a misconception and, in
many centers, SB still is the most popular method, even in
more complicated types of rhegmatogenous RD.19 There-
fore, over the past 20 years patients with comparable RDs
have been and still are treated with completely different
surgical methods, based mostly on surgeons’ individual
preferences. This clinical problem is the starting point of the
SPR Study as a prospective randomized multicenter trial
comparing the functional and anatomical outcomes of SB
and PPV in more complicated types of rhegmatogenous RD.
Interpretation
The SPR Study yielded different results for the 2 subgroups
of the trial—phakic and pseudophakic/aphakic patients—
leading to different recommendations regarding the choice
of operating method. In the phakic subgroup, a statistically
significant advantage of SB over PPV could be found re-
garding the main end point, change in BCVA, as well as the
secondary end point of cataract development. No differ-
ences regarding anatomical outcome and postoperative PVR
rate could be seen. This is the first study demonstrating an
advantage of SB over PPV in phakic patients with more
complicated types of rhegmatogenous RD. Regarding cata-
ract development, this complication has been known to

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 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment

Pars Plana Vitrectomy (PPV) in the Treatment of Retinal Detachment

SB Anatomical Success PPV Success
Primary Final Functional Success n Primary Final Functional Success
91% 100% Mean logMAR, 0.42 47 91% 100% Mean logMAR, 0.45
70% 92% Not given 87 97% 100% Not given
93% 98% Not given 40 83% 100% Not given
83% 95% 37.5% decimalⱖ0.5 32 84% 100% 44% decimalⱖ0.5

70% Snellen median, 6/36 20 80% Snellen median, 6/60

80% 100% Mean logMAR, 0.8⫾0.6 22 91% 100% Mean logMAR, 0.5⫾0.4
76% 100% Decimal mean, 0.19⫾0.15 25 84% 100% Decimal mean, 0.28⫾0.12

68.2% 85% Mean logMAR, 0.96⫾0.68 99 62.6% 92% Mean logMAR, 0.96⫾0.62

83% 95% Mean logMAR, 0.40 75 94% 99% Mean logMAR, 0.33

occur after PPV since publication of the report of the very
first series of patients.20 However, cataract progression has
also previously been noted after SB; this is the first study to
demonstrate a significant difference in cataract development
after SB versus PPV based on the LOCS in a randomized
prospective multicenter trial. One could argue that cataract
surgery does not mean a substantial clinical problem today
and should not be used as an argument against PPV. How-
ever, the visual disability associated with cataract develop-
ment, loss of accommodation in younger patients, necessity
and costs of more frequent follow-up examinations, and
surgery and additional risks associated with cataract surgery
are all disadvantages that cannot be neglected. We have to
emphasize that patients with significant cataract develop-
ment were excluded from main end point analysis in this
study and that surgeons were encouraged to perform cata-
ract surgery on patients with significant cataract develop-
ment during follow-up. Our study results show that patients
in the SB group achieved better outcomes even after ex-
cluding significant cataracts. We are of the opinion that this
is important new information for vitreoretinal surgeons on
which the choice of operating method in the treatment of
rhegmatogenous RD of medium complexity in phakic pa-
tients can be based.
In the pseudophakic/aphakic trial, patients undergoing
PPV showed a significantly greater proportion of primary
success and a lower rate of retina-affecting secondary pro-
cedures than the SB group. As in the phakic trial, we think
that this is important new information for vitreoretinal sur-
geons when making their choice regarding the choice of
treatment options. Ancillary analysis showed that PPV com-
bined with additional scleral buckling was particularly suc-
cessful. Although the use of an additional buckle was not
determined by a randomization procedure, these available
data seem to be in favor of the use of an additional buckle
when performing PPV in pseudophakic patients. Further
analysis will have to be performed to investigate why PPV
offers an advantage over SB in pseudophakic patients and
why additional buckling in combination with PPV seems to
increase the anatomical success rates of PPV even further.
Break characteristics differ in pseudophakic and phakic
patients with RD; in pseudophakic patients, more round
holes are seen and the breaks are smaller, on average. It
might be that the internal search for breaks that can be
performed during PPV enables identification of more breaks
intraoperatively. In addition, missed breaks might be se-
cured with the additional encircling band that is combined
with PPV. Interestingly, in the phakic group no benefit was
seen when combining PPV and additional buckling. Based
on our data, further studies are warranted regarding the use
of additional buckling elements in rhegmatogenous RD
surgery and the possible reasons why PPV achieves better
anatomical results in pseudophakic patients with RD.
We are aware that some aspects of the final study design
are debatable. As is the case in most multicenter prospective
clinical trials, particularly surgical trials comparing differ-
ent methods that include many variations in the technique,
the final trial design resembles a compromise between dif-
ferent views on a controversial topic and the practicability
in a multicenter clinical setting. At first, the participating
surgeons on site performed the evaluation of inclusion and
exclusion criteria. This process is a possible source of bias,
as study surgeons might judge preoperative situations dif-
ferently. To minimize the variations in interpretation of
inclusion criteria, only experienced study surgeons were
allowed to make the decision about study inclusion. In
addition, all study surgeons were instructed about the ap-
plication of inclusion criteria during a training meeting and
at the initial monitoring visit before recruitment for the
study. Finally, rhegmatogenous RD very often presents in
an emergency setting with little time available between the
initial examination and the planned procedure. With only
limited availability of photographic documentation under
these circumstances and the unavailability of a 24-hour
expert review committee of inclusion criteria within the
framework of this study, we think that central monitoring of
inclusion criteria is not a suitable option for studies on the
surgical treatment of rhegmatogenous RD.

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Generalizability
The study was conducted as a randomized prospective mul-
ticenter clinical trial. It was our intention neither to conduct
an experts-only study nor to include patients during the
individual learning curve every surgeon faces when per-
forming the first cases of more difficult types of rhegmat-
ogenous RD surgery. Thus, a minimum number of 100
surgeries of each method was required before a surgeon
could recruit patients for this study. In total, 45 surgeons in
25 institutions in tertiary centers of 5 European countries
recruited patients in this trial. Centers, which normally
would favor SB in the majority of cases, were included as
well as those performing more PPV.11 Therefore, the study
gives a more realistic picture of the real-life situation of
rhegmatogenous RD surgery to date compared with single-
center series of highly experienced surgeons or those with
particular qualities or preferences in one of the two meth-
ods. Recruitment for the study was started in 1998. No
additional major advance has been incorporated into daily
practice since that time. Summarizing these points, we are
of the opinion that the results of the SPR Study can be
transferred to state-of-the-art clinical practice in vitreoreti-
nal surgery.
Overall Evidence
In recent years, the choice of surgical technique for the
treatment of medium-complexity rhegmatogenous RD
shifted more and more towards PPV.12,18 Yet, as pointed out
in several editorials on the topic, no data have been avail-
able up to now to provide scientific evidence for supporters
or opponents of this trend towards PPV alike.13,21 This gap
is now filled by the results of the SPR Study. To the best of
our knowledge, no other prospective multicenter random-
ized trial of SB versus PPV in a comparable study popula-
tion has been completed to date.
Several retrospective and 3 prospective trials of PPV
versus SB in rhegmatogenous RD surgery have been re-
ported (Table 5). However, these studies were conducted
retrospectively3,6 – 8,22; were single-center studies only5,9,10;
investigated a rather small number of patients3,9,10; ob-
served all patients or a significant proportion of the study
group for less than a year4,6,9,10,22; or examined a group of
patients with preoperative PVR grade B,4 which is seen only
in a small proportion of patients with primary rhegmatog-
enous RD in European centers.11 Therefore, the internal
validity of previous studies is debatable, and consequently,
the generalizability is restricted.
Only 3 articles comparing PPV and SB interpret their
data in favor of one of the two methods. Tewari et al found
greater complication rates of PPV compared with SB and,
therefore, recommend SB in pseudophakic patients with
unseen breaks.10 Sharma et al favor PPV in pseudophakic
detachments because of “better long term visual and ana-
tomical outcomes.” A significant difference between the
functional results of the two groups could be found, how-
ever, only at the final follow-up examination; all other
comparisons could not achieve statistical significant values,
the follow-up was 6 months, and only 25 patients were
2152
included in both groups.9 Oshima et al found a small sub-
group of patients with macula-off detachments of long
duration or preoperative hypotony in which PPV led to a
faster visual rehabilitation compared with SB. Similarly, no
differences were seen at the last point of follow-up.7
The comparison of anatomical success rates of trials in
RD surgery is complicated by several factors. First, studies
vary in their follow-up, and greater redetachment rates can
be seen with a longer follow-up. In our study, any redetach-
ment within the 1-year follow-up would count as a primary
failure. Second, cases in which the retina is not fully reat-
tached might in some series still be counted as successful
rettachments (e.g., a small area of SRF on the peripheral
buckle that is not endangering the central retina; residual,
only slowly regressing SRF after SB). Third, in a significant
number of cases additional procedures have to be performed
to ensure that the retina remains attached after the initial
procedure (e.g., additional laser photocoagulation, intravit-
real gas injection). These additional procedures are often not
taken into account when analyzing the primary failure rate
of RD surgery. We therefore used a relatively strict defini-
tion for primary anatomical success that was influenced by
any type of incomplete retinal reattachment and any type of
secondary retina-affecting surgery, even if the retina was
attached before and after the retina-affecting procedure.
This is not to be mistaken for the redetachment rate with the
standard interpretation, which was also calculated to allow
comparison of our results with those in the literature.
Comparing our anatomical success rates and postopera-
tive PVR, greater success rates are given in the majority of
published series of PPV and SB. For PPV, a review of 25
reports of series showed primary success rates of 85% for
phakic patients and 91% for pseudophakic patients, com-
pared with 73% and 78% in the SPR Study, respectively.2 It
is of interest that the 3 reported prospective PPV series had
primary success rates (between 62% and 84% [Table 5])
much lower than those of retrospective series. Postoperative
PVR was noted in between 0% and 19% of patients in
retrospective PPV series. In 3 prospective trials, the PVR
rates were 4%, 15% and 34%.4,9,10 In the SPR Study,
postoperative PVR rates were 17.7% in the phakic subgroup
and 15.3% in the pseudophakic one. Our PVR rate and the
final success rate of 97.4% and 94.6% for phakic and
pseudophakic rhegmatogenous RDs compare favorably
with the values given in the literature (Table 5).
Results of recent series of SB are more difficult to
compare with our results. These reports usually do not
include more complicated situations of RD, because they
are now more often treated with PPV. This might signify a
selection bias, and better results have to be expected. Re-
cently reported larger series of SB achieved primary ana-
tomical success rates between 82% and 88%.23–26 Prospec-
tive series again show lower success rates for SB, between
68% and 76% (Table 5). In the SPR Study, primary success
rates were 73% in the phakic subgroup and 61% in the
pseudophakic subgroup. The PVR rate in recent retrospec-
tive series of SB varied between 4% and 11%. In the
prospective trials of SB, postoperative PVR grade B or C
was seen in 20%, 25%, and 37%.4,9,10 In our study, PVR
 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment
grade B or C could be seen in 12.9% of phakic and 21.6%
of pseudophakic patients treated with SB. The final success
rates of 96.9% and 94.4% in the phakic and pseudophakic
groups again compare favorably with the results published
so far.
Comparing our results with the majority of recently
published studies on rhegmatogenous RD surgery, the re-
detachment rates of this trial seem to be greater than might
have been expected. Several reasons can be given to explain
this finding. First, only complicated RDs with difficult break
situations were included in this trial; the majority of rela-
tively uncomplicated RDs (single break and localized de-
tachment) that would increase the anatomical success rates
were excluded. Second, our criteria for redetachment were
very strict, and some situations (e.g., a small peripheral area
of SRF) that were counted as redetachments would qualify
as anatomical successes in other studies. Third, the partic-
ipation of a large number of surgeons could have led to the
inclusion of a broader variety of individual surgical skills
(the role of the individual surgeon will be analyzed in depth
in further studies). Finally, the prospective nature of this
trial might account for some differences compared with
retrospective trials. Success rates reported in retrospective
trials are commonly better than those in prospective trials of
the same topic. Possible reasons for this phenomenon are
selection bias in retrospective series, different study popu-
lations, different definitions of primary success, single sur-
geons operating with their preferred technique, different
techniques of verification of retinal reattachment, and oc-
currence of selective reporting of study outcomes (e.g., a
small chance of negative outcomes being submitted or ac-
cepted for publication).27 Overall, it appears that the out-
come of the SPR study compares favorably with those of
other prospective trials but is worse compared with those of
previously published retrospective series. Because this
study was conducted as a prospective multicenter trial with
an intention-to-treat analysis, we do think that our results
reflect the situation of RD surgery in daily clinical practice.
We therefore are of the opinion that our study reaches a
greater level of clinical evidence than previously published
trials on this subject.
Comparisons of the functional results of our study with
those of previous trials are difficult to undertake. Apart from
the differences in the preoperative characteristics of in-
cluded patients with a significant influence on postoperative
BCVA (e.g., preoperative PVR, macula-off RD), the meth-
odological dissimilarities are vast. The SPR Study is the first
trial of RD surgery to use ETDRS charts for measurement
of BCVA. None of the previous studies, including the
recently published prospective trials, used this method,
which must be regarded as the standard tool for VA mea-
surements in clinical trials. In addition, different standards
of presenting functional results are applied, and some stud-
ies do not present functional results at all. One similarity,
however, can be seen when comparing our results with
those published: no significant differences can be seen re-
garding the functional outcomes when comparing PPV with
SB in almost all studies at any time point. Only in the study
by Sharma et al did PPV achieve better functional results at
the last follow-up at 6 months.9 Our results correspond to
those of Oshima et al, with mean logMAR values of 0.42
(SB) and 0.45 (PPV) versus our results of 0.329 and 0.460
in the phakic and pseudophakic subgroups of SB and 0.484
and 0.377 in the PPV treatment arms, respectively.7 All
other trials comparing SB and PPV, including 3 prospective
studies, seem to have achieved significantly worse func-
tional results than those of all SPR Study subgroups. How-
ever, as mentioned above it has to be emphasized that the
study populations in these trials differ significantly from our
study’s, which might explain the differences of functional
results.
In summary, our study is the first prospective large-scale
randomized multicenter clinical trial involving a high num-
ber of centers, surgeons, and patients in 5 different countries
reported on this subject. Based on the conduct and proper-
ties, our study has recommendation level A1b for efficacy
proof of a therapeutic intervention, according to the notation
of the Oxford center of evidence-based medicine.28 The
study results reflect the situation of rhegmatogenous RD
surgery in daily clinical practice, and due to its scientific
approach, the study reaches the greatest level of clinical
evidence compared with previously published trials on this
subject.
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 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment
Appendix 1: Active Participants of the
Scleral Buckling versus Primary
Vitrectomy in Rhegmatogenous Retinal
Detachment Study Group
Principal Investigators
M. H. Foerster, R.-D. Hilgers, (W. Lehmacher).
Study Coordinator
C. Wei␤.
End Point Committee (Alphabetical Order)
K. U. Bartz-Schmidt, N. Bornfeld, M. H. Foerster, H.
Heimann, R.-D. Hilgers, C. Wei␤.
Advisory Board
M. H. Foerster, P. Bauer, K. Lemmen.
Biostatisticians and Data Managers
R.-D. Hilgers, C. Wei␤, M. Nodov.
Active Study Surgeons (Alphabetical Order)
K. U. Bartz-Schmidt, S. Binder, S. Bopp, N. Bornfeld, C.
Dahlke, F. Faude, M. H. Foerster, W. Friedrichs, V. P.
Gabel, J. Garweg, A. Gaudric, W. Göbel, S. Grisanti, C.
Groenewald, L. L. Hansen, O. Hattenbach, K. Hille, H.
Hoerauf, F. Holz, P. Janknecht, J. Jonas, U. Kellner, B.
Kirchhof, F. Koch, F. Körner, H. Laqua, Y. LeMer, M.
Löw, A. Lommatzsch, K. Lucke, P. Meier, E. Messmer, U.
Mester, M. Partzsch, D. Pauleikhoff, I. Pearce, J. Roider, H.
Schilling, W. Schrader, N. Schrage, U. Stolba, P. Walter, B.
Wiechens, S. Wolf, D. Wong.
Study Nurses
N. Alteheld, E. Biewald, L. Garnett, M.A. Macek, G.
Rössler.
Local Study Coordinators
N. Feltgen, M. Gök, B. Moustafa, D. Ottenberg, S. Pape, J.
Slater.
Appendix 2
Sample Size
In both subtrials, a sample size of 200 patients in each arm
was intended. In an amendment, the planned adaptive in-
terim analysis in the pseudophakic trial was omitted because
of the low recruitment rates. Finally, the intended sample
size of 200 per treatment group was achieved in the phakic
trial only. Recruitment was stopped in the pseudophakic
trial parallel to the phakic trial in accordance with the
protocol amendment. Although the actually recruited num-
bers of 133 and 132 patients per group in the pseudophakic
trial fell below the initial target (␣ ⫽ 0.05; power, 90%;
20% dropout), a post hoc power analysis (␣ ⫽ 0.05; power,
80%) showed that the intended medium effect size of 0.35
for the primary end point was detectable in this trial.
Randomization
The 2 trials were carried out as prospective randomized
controlled clinical trials with separate randomization
schemes, each involving a parallel-group design. Random-
ization was performed by letters enclosed in sealed and
opaque envelopes with consecutive patient numbers indi-
cating the operation method to be applied. The randomiza-
tion codes were balanced in permuted blocks of varying
size, stratified by surgeon. Randomization lists were gener-
ated by the documentation center using S-PLUS (version
3.4, release 1 for IBM RS/6000, AIX 3.2.5, Mathsoft Inc.,
Cambridge, MA).
Allocation Concealment
Randomization by envelope was preferred because a rele-
vant proportion of the patients was expected to be treated
outside normal office working hours. Although the date and
time of opening of the randomization envelope had to be
documented on the randomization letter, bias due to alloca-
tion concealment could not be excluded. Accordance to the
guidelines in handling of the envelopes was verified at
monitoring visits. In addition, the randomization list was
kept sealed in the documentation center. After confirmation
of the patient’s eligibility for the study, randomization was
performed by opening the next sequential envelope from the
randomization boxes.
Blinding
Blinding of the assessment of the main end point criterion,
change in BCVA, was not performed for practical reasons.14
The secondary end point criteria were assessed by the end
point committee in a masked fashion using standardized
fundus and anterior segment photographs. These included
retinal and macular attachment, macular pucker and PVR,
lens opacity, and secondary cataract.
Statistical Methods
Both surgical methods were compared on the basis of the
changes in BCVA using a 2-factor analysis of covariance
(factor, operating method; block factor, surgeon; no inter-
action; covariate baseline BCVA; test of the main effect
operating method; type II sums of squares at a 2-sided 5%
significance level).
In addition, the secondary end point criteria rate of PVR,
primary anatomical success, and final anatomical success
were analyzed by Mantel–Haenszel chi-square tests strati-
fied by surgeon. Further, the end point criterion number of
reoperations was evaluated by van Elteren’s version of a
Wilcoxon rank sum test stratified by surgeon. Surgeons with
⬍10 recruited patients were grouped together. We com-
puted 2-sided P values only for comparison with the 2-sided
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 Ophthalmology Volume 114, Number 12, December 2007

5% significance level. We used various SAS procedures to
analyze frequencies and fit ANOVA models to the data
(GLM). Note that only categorical variables are used as
influencing factors in ANOVA models, but if there are also
continuous variables as influencing factors, the ANOVA
model migrates to an analysis of covariance model. Corre-
sponding F tests, however, can be applied even in this
situation. Statistical analysis was performed using SAS (re-
lease 9.1.3 SP 2) on Windows 2000 Service Pack 4 (Mi-
crosoft Corp., Redmond, WA). SAS proc freq and proc glm
are used to calculate statistical tests. Database access was
performed using a 4th Dimension (version 6.8.6, 4D Inc.,
San Jose, CA) Open DataBase Connectivity Interface.

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 Heimann et al 䡠 Scleral Buckling versus Primary Vitrectomy in Retinal Detachment

Figure 3. Scatter diagram and regression line of baseline best-corrected visual acuity (BCVA) compared with final BCVA in the phakic trial. logMar ⫽
logarithm of the minimum angle of resolution.

Figure 4. Scatter diagram and regression line of baseline best-corrected visual acuity (BCVA) compared with the final BCVA in the pseudophakic trial.
logMar ⫽ logarithm of the minimum angle of resolution.

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 Ophthalmology Volume 114, Number 12, December 2007

Table 4. Breach of Inclusion Criteria and Protocol Deviations

Phakic Patients Pseudophakic Patients

Characteristics SB (n ⫽ 209) PPV (n ⫽ 207) SB (n ⫽ 133) PPV (n ⫽ 132)
Breach of inclusion criteria* [n (%)]
Morphology of retinal detachment 7 (3.3) 7 (3.3) 9 (6.7) 5 (3.7)
Concomitant eye disease influencing BCVA 2 (0.9) — — 3 (2.2)
Medical history 3 (1.4) 2 (0.9) 1 (0.75) 4 (3.0)
Protocol deviations* [n (%)]
Performing PPV after initial SB 6 (2.8) — 8 (6.0) —
Performing SB instead of PPV — 1 (0.4) — 1 (0.7)
Performing cataract surgery combined with PPV — 5 (2.41) — —
PPV with tamponades other than sulfur hexafluoride/air — 10 (4.8) — 5 (3.7)
Total no. of cases with breach of inclusion criteria and/ 16 (7.6) 21 (10.1) 14 (10.5) 16 (12.1)
or protocol violations†

BCVA ⫽ best-corrected visual acuity; n ⫽ no. of observations; PPV ⫽ primary pars plana vitrectomy; SB ⫽ scleral buckling surgery.
*Classified after case review by the end point committee.
†
Some cases had protocol deviations and breach of inclusion criteria.

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