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A 27-Gauge Instrument System For Transconjunctival Sutureless Microincision Vitrectomy Surgery
A 27-Gauge Instrument System For Transconjunctival Sutureless Microincision Vitrectomy Surgery
Objectives: To evaluate the efficiency, preliminary safety, and feasibility of a 27-gauge instrument system for
transconjunctival microincision vitrectomy surgery (MIVS) in a variety of vitreoretinal diseases.
Design: Experimental, interventional case series.
Participants: Thirty-one eyes (31 patients) underwent a variety of vitreoretinal procedures using the 27-
gauge transconjunctival MIVS system to treat epiretinal membrane (n ⫽ 10), idiopathic macular holes (n ⫽ 7),
diabetic vitreous hemorrhage (n ⫽ 5), vitreous opacity with suspicion of intraocular lymphoma (n ⫽ 4), focal
diabetic traction retinal detachment (n ⫽ 3), macular traction syndrome (n ⫽ 1), and macular edema secondary
to central retinal vein occlusion (n ⫽ 1).
Methods: We developed a 27-gauge instrument system that includes an infusion line, a high-speed vitreous
cutter, an illumination system, and a variety of vitreoretinal instruments, such as membrane forceps and
sharp-tipped endophotocoagulation probes. The duty cycle of the 27- and 25-gauge cutters was measured for
several cut rates using a high-speed imaging camera. Infusion and aspiration rates were measured using
balanced saline solution (BSS) and porcine vitreous with different aspiration levels. Surgical outcomes, including
anatomic success, visual outcomes, operating times, and intraoperative and postoperative complications, were
evaluated.
Main Outcome Measures: Duty cycle of cutters, infusion and aspiration rates, and surgical results of
27-gauge vitrectomy.
Results: Although the infusion and aspiration rates of the 27-gauge system measured in BSS were reduced
to an average of 62% and 80%, respectively, compared with those of the 25-gauge system, the duty cycle of the
27-gauge cutter, 61% at 1000 cpm and 38% at 1500 cpm, was equal to or better than those of the 25-gauge
cutter (62% and 28%, respectively). Analysis of the fluid dynamics showed that vented gas-forced infusion can
be set to range from 20 to 30 mmHg to control intraocular pressure (IOP) during 27-gauge vitrectomy. Anatomic
success was achieved in all study eyes (100%); 20 eyes (65%) had visual improvement of 3 lines or more. No
eyes required conversion to larger gauge instrument. All sclerotomies self-sealed without hypotony (IOP ⱕ 7
mmHg) from 1 day postoperatively.
Conclusions: Although the fluid dynamics and cutting efficiency of 27-gauge instruments are lower com-
pared with 25-gauge MIVS, the 27-gauge system is feasible and may reduce concerns about wound sealing-
related complications in selected cases.
Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
Ophthalmology 2010;117:93–102 © 2010 by the American Academy of Ophthalmology.
Recent establishment of transconjunctival microincision vit- incidence of bacterial contamination or postoperative en-
rectomy surgery (MIVS) with 25- or 23-gauge instrumen- dophthalmitis, are critical concerns accompanying the use
tation has provided potential advantages over traditional of and expanding indications for MIVS.9 –16 Changing the
20-gauge surgery, including faster wound healing, less con- insertion technique from 1- to 2-step entry4 or from vertical
junctival scaring, decreased operating time, elimination of to angled insertion17–19 may facilitate the efficiency of self-
astigmatism, improved patient comfort, and less postopera- sealing, but it is not always beneficial in every case, espe-
tive inflammation with early visual recovery.1– 8 These ad- cially in young or myopic eyes with thin sclera and liquefied
vantages are attributed to a self-sealing sclerotomy that vitreous gel or in fluid-filled eyes after vitrectomy with
obviates the need for conjunctival peritomy and suturing. extensive removal of peripheral vitreous.10 –12
However, wound sealing-related complications, such as hy- Before the introduction of 25- or 23-gauge MIVS, much
potony, choroidal detachment, and an increasingly higher smaller-gauge instrumentation had been used for postoper-
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Oshima et al 䡠 27-Gauge Vitrectomy
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Oshima et al 䡠 27-Gauge Vitrectomy
Results
Table 2. Comparison of Specifications and Stiffness of the 25- and 27-Gauge Vitreous Cutters
*The commercially available 25-gauge vitreous cutter is from Alcon Laboratories Inc.
†
The 27-gauge vitreous cutter is produced by Dutch Ophthalmic Research Center International BV.
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Ophthalmology Volume 117, Number 1, January 2010
Size 0 cpm 1000 cpm 1500 cpm 2000 cpm 2500 cpm
25-gauge* 100% 62% 28% NA NA
27-gauge† 100% 61% 38% 21% 7%
rates for the 27-gauge cutter explored ranged from 1000 to 1500 Figure 10. Infusion rates of BSS using the 27- and 25-gauge infusion lines
cpm on the basis of the duty cycle analysis, the BBS aspiration are measured at different pressures generated by the VGFI system. The
rates ranging from 0.05 to 0.07 ml/sec at the aspiration vacuum safety range of the pressure generated by VGFI is estimated to be set
level of 600 mmHg were estimated to be the most efficient for between approximately 20 and 30 mmHg. The infusion rates of the
27-gauge vitrectomy. Under this condition, the safety range of the 27-gauge system are 60% and 62% at a VGFI of 20 and 30 mmHg,
pressure generated by VGFI, which generates the infusion flow respectively, compared with that of the 25-gauge system. cpm ⫽ cuts per
supply, is estimated to be adjusted between 20 and 30 mmHg (Fig minute.
10). The 27-gauge vitreous cutter had aspiration rates of 80% in
BSS (Fig 11) and 40% in porcine vitreous (data not shown)
compared with that of a 25-gauge cutter when operated at maximal
vacuum level (600 mmHg) with a cutting speed of 1500 cpm, the 27-gauge sclerotomies in all 31 eyes were self-sealed without
maximal cutting speed for the 25-gauge vitreous cutter. suture placement after simple removal of 27-gauge instruments.
During the study period from June 2007 to November 2008, 31 The mean preoperative IOP was 14.6⫾3.0 mmHg (range, 10 –19
eyes of 31 patients (17 men and 14 women) were enrolled and mmHg), and the mean postoperative IOPs at 1 day, 1 week, and the
underwent transconjunctival 27-gauge MIVS for a variety of vit- final visit were 14.7⫾5.1 mmHg (range, 9 –31 mmHg), 14.5⫾3.1
reoretinal diseases, including epiretinal membranes (10 eyes), id- mmHg (range, 9 –22 mmHg), and 13.8⫾2.4 mmHg (range, 9 –19
iopathic macular holes (7 eyes), diabetic vitreous hemorrhage (5 mmHg), respectively (Fig 12). There were no significant preoper-
eyes), diagnostic vitrectomy for vitreous opacity with suspicion of ative and postoperative IOP differences at any follow-up visits
intraocular lymphoma (4 eyes), focal diabetic traction retinal de- (P⫽0.203). Although the mean day 1 postoperative IOP in eyes
tachment (3 eyes), macular traction syndrome (1 eye), and macular with long-acting gas or air tamponade (17.2⫾6.8 mmHg) was
edema secondary to central retinal vein occlusion (1 eye). The higher than that in eyes without gas tamponade (13.4⫾3.4 mmHg),
mean patient age ⫾ standard deviation was 62.9⫾8.3 years (range, the differences between groups did not reach significance through-
40 – 84 years). The mean axial length was 24.7⫾1.3 mm (range, out the follow-up period (P⫽0.134). All study eyes achieved
22.1–27.8 mm). The mean postoperative follow-up time was anatomic success with successful removal of an epiretinal mem-
6.9⫾3.5 months (range, 3–20 months). The clinical data from the brane, ILM, or both, reattachment of the detached retina, closure of
31 eyes are shown in Table 4 (available at http://aaojournal.org). the macular holes, or clearance of the clouded media.
Among the 31 eyes, the mean operating time was 34.3⫾18.8 The VA levels of the 31 study eyes at baseline and the last
minutes (range, 10 – 88 minutes). All surgeries were completed visits are shown in Figure 13. The mean preoperative VA was 0.17
using 27-gauge instruments without conversion to 25- or 23-gauge
in any cases. Cataract surgery with intraocular lens implantation
was simultaneously performed in 19 eyes complicated with cata-
racts. Fluid–air exchange followed by instillation of 20% sulfur
hexafluoride gas or air tamponade alone was performed in 11 eyes
(35%). No intraoperative complications occurred except for a
peripheral retinal break in the 1 eye. At the end of surgery,
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Oshima et al 䡠 27-Gauge Vitrectomy
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Ophthalmology Volume 117, Number 1, January 2010
shaft increases the shaft rigidity.24 By fully inserting the complicated vitreoretinal pathologies. Although the perfor-
shaft into the vitreous cavity and using the root of the shaft mance of the current 27-gauge vitreous cutter is not yet
as a fulcrum point, the 27-gauge light pipe can be used to adequate for treating complex proliferative vitreoretinal pa-
control ocular movements during surgery. The sharp tip of thologies, which sometimes require extensive peripheral
the light pipe, similar to a 27-gauge needle, facilitates 1-step vitreous shaving and manipulations, multiple instrument
transconjunctival entry into the vitreous cavity. The 29- exchanges, or a bimanual technique, our results showed that
gauge inner optical fiber with a cone-shape tip that gener- the 27-gauge vitrectomy system is feasible and adequate for
ates 25 output lumens provides sufficient wide-angle endoi- treating eyes with a macular hole, epiretinal membrane,
llumination for intraocular manipulation as functional as macular edema, macular traction syndrome, simple vitreous
chandelier illumination. Because of the short (13 mm) shaft hemorrhage, focal traction retinal detachment, or vitreous
length, inadvertent contact with the retinal surface is un- biopsy for cytologic diagnosis. The pathologies treated in
likely, as is theoretical retinal phototoxicity with a conven- this series are the most amenable to begin using the 27-
tional light pipe. gauge vitrectomy system with the currently available instru-
Development of a practical 27-gauge vitreous cutter was ments, because no eyes in our series required conversion to
the most critical step for establishing a 27-gauge vitrectomy larger-gauge instrumentation during 27-gauge vitrectomy
system. We developed a 27-gauge cutter with its port area and were more likely to have good postoperative anatomic
larger than that of a commercially available 25-gauge cutter. and visual recoveries.
The shorter shaft length (25 mm) is similar in rigidity to that The setting for 27-gauge vitrectomy is similar to that of
of a conventional 25-gauge cutter, thus eliminating instru- 23- and 25-gauge instrumentation. However, special tech-
ment fragility during clinical use. Because a trocar-cannula niques for creating a self-sealing wound, such as angled-
system is no longer needed for every case in 27-gauge incision technique or a 2-step entry method, are no longer
vitrectomy, the shaft length used to pass through a cannula required. The 27-gauge vitrectomy can begin immediately
is not needed. Therefore, in the current study the 25-mm after creating sclerotomies at pars plana by simple perpen-
shaft length was sufficient to perform core and peripheral dicular insertion using 27-gauge instruments, most of which
vitrectomy in eyes with the axial length from 22 to 28 mm. are designed for 1-step entry without a pre-incision. Be-
The actual performance (cutting and aspirating efficiency) cause of its small gauge size with less risk of vitreous
of a vitreous cutter is related to both the gauge size and the incarceration to the scleral wounds, 27-gauge vitrectomy
duty cycle.23 Although the internal diameter (0.275 mm) of can be performed without use of a trocar-cannula system in
the 27-gauge vitreous cutter is smaller than that of the patients undergoing treatment of simple vitreous hemor-
25-gauge vitreous cutter (0.347 mm), the duty cycle of the rhage or diagnostic vitrectomy, which has less chance for
27-gauge cutter is equal to or slightly better than that of a instrument exchanges during surgery. After simply remov-
conventional 25-gauge cutter with cut rates ranging from ing all instruments, surgery can be concluded at once with
1000 to 1500 cpm. The shortened shaft also may contribute all sclerotomies self-sealed without suture placement.
to reduced fluid resistance during aspiration. Therefore, the The anatomic outcomes of 27-gauge vitrectomy in this
actual aspiration rate of the 27-gauge cutter in BSS and pilot study were favorable and comparable to those reported
porcine vitreous reached 80% and 40% of that of 25-gauge using 25- or 23-gauge vitrectomy systems.2,3,5,27 Macular
cutter with an aspiration level of 600 mmHg and a cut rate edema caused by epiretinal membranes, vitreoretinal trac-
of 1500 cpm. However, we also found that 27-gauge vit- tion, or retinal vein occlusion resolved in 11 of 12 eyes after
rectomy with a cut rate greater than 2000 cpm may not be vitrectomy with epiretinal and ILM peeling using 27-gauge
practical because of a poor duty cycle less than 21%. instruments. Successful macular hole closure was achieved
Further advances to optimize the balance between the pneu- in all 7 eyes after vitrectomy with ILM peeling and gas
matic pressure and the strength of the spring coil of the tamponade. Performing diabetic vitrectomy with the 27-
pneumatic cutter are needed to improve the duty cycle of the gauge system allowed successful reattachment of the de-
27-gauge cutter at a higher cut rate. tached retina in 3 eyes and removal of a dense vitreous
The balance between the aspiration rate of the vitreous hemorrhage in all 5 eyes despite 2 eyes with a self-limited
cutter and the infusion rate is important to maintain the IOP recurrent hemorrhage. Vitrectomy to obtain cytologic spec-
in a safety range during vitrectomy. The aspiration rate of imen using the 27-gauge cutter effectively resulted in the
the 27-gauge vitreous cutter in BSS ranged from 0.05 to diagnosis of primary intraocular lymphoma in 3 of 4 eyes
0.07 ml/sec with the cut rate ranging from 0 to 1500 cpm. and late-onset bacterial endophthalmitis in 1 eye. There was
Therefore, the pressure of the VGFI to maintain the infusion significant improvement in the mean preoperative to mean
rate within this range can be set from approximately 20 to postoperative VA in all study eyes (P⬍0.001) and in the
30 mmHg (Fig 10). Because the vitreous humor is consid- subgroups with epiretinal membranes (P ⫽ 0.001), idio-
erably more viscous than BSS, the actual aspiration rates pathic macular holes (P⬍0.001), and diabetic complications
during vitrectomy should be lower than the aforementioned (P ⫽ 0.006). Overall, the visual improvement exceeding 3
aspiration rate measured in BSS. This pressure range allows lines was achieved in 20 eyes (65%) at the final follow-up
for a greater margin of safety for the IOP to prevent hypot- visit. No eyes had significant visual impairment after sur-
ony or inadvertent ocular hypertension during vitrectomy. gery or any limitations or untoward effects from the 27-
In the current study, we performed 27-gauge vitrectomy gauge instrumentation. Although we may have overesti-
in 31 eyes of 31 patients and demonstrated the feasibility mated the current visual results because cataract surgery
and preliminary safety of this new system to treat less- simultaneously performed in 61% of study eyes may have
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Oshima et al 䡠 27-Gauge Vitrectomy
contributed partially to the visual recovery, these results retinal detachment or endophthalmitis developed in the cur-
were comparable to those in our previous series in which we rent series, suggesting that the wound sealing-related com-
used the 25-gauge system.27 plications occasionally encountered with an unsutured scle-
By using the 27-gauge system, opening and closing rotomy using the 23- or 25-gauge system can be minimized
procedures can be simplified further than for the current 23- by using the smaller 27-gauge system.
or 25-gauge systems, which may contribute to a decrease in This series had potential weaknesses in that it was ret-
the total operating time for this system. Nevertheless, the rospective, uncontrolled, and noncomparative, had a small
operating time using the 27-gauge system for treating chal- number of cases, and reflected the initial experience from 1
lenging cases, such as traction retinal detachment, must be institution. Nevertheless, the feasibility and safety of 27-
longer than for macular diseases, and theoretically it may be gauge vitrectomy in selected cases have been confirmed for
longer than when using 23-gauge or conventional 20-gauge the first time by the current study. Although the develop-
instrument because of the substantially lower infusion and ment of 27-gauge vitrectomy is an ongoing project and has
aspiration rates of the 27-gauge vitrectomy system. How- not yet been established as a widely accepted system for all
ever, the overall mean operating time of 34.3 minutes cases at present, it has great potential usefulness and advan-
(range, 10 – 88 minutes) in the current series with 27-gauge tages that can contribute to the quality and safety of MIVS.
instruments did not differ greatly from that (mean, 37.4 Another advantage of MIVS is that it is a minimally inva-
minutes; range, 28 –74 minutes) with the 25-guage system, sive surgery. Surgeons should pay attention more to reli-
as we previously reported.27 This range of operating time ability and safety rather than to shorter surgical time. A
seems to be within acceptable limits. Although a retinal tear gently performed surgery with slow inflow and outflow,
inadvertently occurred in 1 eye during peripheral vitreous elimination of the risk of wound integrity-related concerns,
shaving despite use of the 27-gauge vitreous cutter, it was and theoretically less postoperative inflammation with 27-
treated with 27-gauge endolaser photocoagulation and not gauge vitrectomy may be the least invasive MIVS at
related to any postoperative complications. Because of its present.
small gauge of nature, wide port design, and shorter dis- In conclusion, the current results confirmed the prelimi-
tance from the cutting port to the tip, the 27-gauge cutter can nary safety and practicality of the 27-gauge instrument
perform several functions concurrently during surgery (i.e., system for transconjunctival sutureless MIVS in selected
as a cutter, aspirator, peeling forceps, and membrane scis- cases. The favorable wound-sealing structures with few
sors). This multifunctionality is especially helpful during postoperative complications and acceptable operating time
diabetic vitrectomy. The blunt tip of the 27-gauge cutter can suggests the potential of the 27-gauge system for treating
be inserted more easily into the spaces between the fibro- macular diseases, simple vitreous opacity or hemorrhage,
vascular membrane and the retina, allowing successful mem- and moderately severe diabetic retinopathy. Similar to the
brane segmentation, dissection, and removal using only the recent evolution of other small-gauge systems, further de-
vitreous cutter without instrument exchange (Video 3, avail- velopment and refinement of the 27-gauge instrument func-
able at http://aaojournal.org). Reducing the use of various tionality and rigidity are under way and critical to the
instruments for manipulation may eliminate sclerotomy- widespread use of this system for the full spectrum of
related complications, save the time required for instrument vitreoretinal diseases in the future.
exchange, and contribute to less-invasive and time-efficient
surgery.
The overall mean IOP before and after surgery was stable References
with no significant difference among the examination time
points. The most remarkable finding in 27-gauge vitrectomy
is that no eyes in our series developed wound sealing- 1. Fujii GY, De Juan E Jr, Humayun MS, et al. A new 25-gauge
related complications such as subconjunctival air bubbles, instrument system for transconjunctival sutureless vitrectomy
conjunctival swelling, or hypotony (ⱕ7 mmHg) from post- surgery. Ophthalmology 2002;109:1807–12.
2. Lakhanpal RR, Humayun MS, de Juan E Jr, et al. Outcomes of
operative day 1 throughout the follow-up period, suggesting 140 consecutive cases of 25-gauge transconjunctival surgery
favorable self-sealing structures of the 27-gauge scleral for posterior disease. Ophthalmology 2005;112:817–24.
wounds. Recurrent vitreous hemorrhage was the only post- 3. Ibarra MS, Hermel M, Prenner JL, Hassan TS. Long term
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CME ⫽ cystoid macular edema; CRVO ⫽ central retinal vein occlusion; ERM ⫽ epiretinal membrane; F/M ⫽ female/male; HM ⫽ hand motions;
PEA ⫽ phacoemulsification and aspiration; PPV ⫽ pars plana vitrectomy; R/L ⫽ right/left; TRD ⫽ traction retinal detachment; VA ⫽ visual acuity;
102.e1
Ophthalmology Volume 117, Number 1, January 2010
IOL ⫽ intraocular lens; IOP ⫽ intraocular pressure; MH ⫽ macular hole; MTS ⫽ macular traction syndrome; PDR ⫽ proliferative diabetic retinopathy;
VH ⫽ vitreous hemorrhage; VO ⫽ vitreous opacity.
102.e2