Clinical science
Br J Ophthalmol: first published as 10.1136/bjo.2008.154385 on 12 April 2010. Downloaded from http://bjo.bmj.com/ on January 8, 2020 at AAO/BJO. Protected by copyright.
State Key Laboratory Cultivation
Base, Shandong Provincial Key
Laboratory of Ophthalmology,
Shandong Eye Institute,
Qingdao, PR China
Correspondence to
Dr Lixin Xie, Shandong Eye
Institute, 5 Yanerdao Road,
Qingdao 266071, PR China;
lixin_xie@yahoo.com
Accepted 22 November 2009
456
Long-term outcome of black diaphragm intraocular
lens implantation in traumatic aniridia
Xiaoguang Dong, Haifeng Xu, Bin Yu, Liang Ying, Lixin Xie
ABSTRACT
Aim To evaluate the long-term outcome of black
diaphragm intraocular (BDI) lens implantation in
traumatic aniridia and investigate the possible cause of
long-term complications.
Methods Medical records of 18 patients (18 eyes), who
had BDI lens implantation for traumatic aniridia at
Shandong Eye Institute from January 1999 to December
2007, were retrospectively reviewed. Ultrasound
biomicroscopy was used to observe the position of lens
haptics. The difference between the eyes with and
without long-term complications was compared.
Results During the follow-up of 41 months (range
12e72), 12 eyes showed a satisfactory visual function,
no capsule membrane was present because of pars plana
vitrectomy performed before or with lens implantation,
and the haptics of BDI lenses were located at the sulcus
or trans-sclerally fixed. Four eyes developed refractory
glaucoma at 6e36 months after the BDI lens
implantation, and three of these had an intact capsule
membrane, with the sulcus fixation of the lens haptics in
two and trans-scleral fixation in one. Corneal
decompensation occurred in six eyes, including the four
with glaucoma.
Conclusions BDI lens implantation is safe and effective
in most traumatic eyes. Glaucoma and corneal
decompensation appear to be the major long-term
complications. The position of BDI lens is crucial for the
long-term outcome.
Aniridia is often recorded in severe traumatic eyes.1
This defect may result in intolerable photophobia and
glare, which consequently impair visual function. It
was reported that nearly one-third of inpatients with
eye problems in China had ocular trauma, among
which the incidence of iris prolapse or deficiency, that
is, the potent aniridia, was higher than 15%.2 3 These
patients with traumatic aniridia desiderate a fine
management and long-lasting good outcome.
Eyelid surgery, iridoplasty, coloured contact lenses,
sunglasses and corneal tattooing have been used to
restore visual function in aniridia, but the results
have not been favourable.4 The black diaphragm
intraocular (BDI) lens has offered another option for
aniridia since it was developed by Sundmacher et al,5
and the short-term outcomes are encouraging.6e9
However, over time, some patients may lose their
initially recovered visual function due to secondary
glaucoma or corneal opacity and may have to receive
an intraocular lens explant, sometimes combined
with penetrating keratopalsty. Reinhard et al10
reported the long-term (mean 46 months) results in
19 congenital aniridia eyes, among which eight eyes
had glaucoma deterioration and development, two
had intraocular lens explantation, and three had
chronic corneal endothelial cell (CEC) loss. In
a report on 25 eyes with traumatic aniridia, glau-
coma developed in six eyes, five of which could not
be controlled by topical medications. Four eyes with
corneal decompensation required corneal trans-
plantation during the follow-up of 42 months.11
According to another investigation on six traumatic
aniridia eyes in an average follow-up of 7 years and
8 months,12 bullous keratopathy occurred in four
eyes and glaucoma in three eyes. Penetrating kera-
toplasty and Ahmed valve implantation were
performed to treat these complications. We also
noticed glaucoma and corneal decompensation after
BDI lens implantation in clinical practice. Moreover,
the mechanism of these long-term complications
after BDI lens implantation remains unclear. The size
of BDI lens may be a contributing factor, but there
has been no strong evidence. To determine the cause
of long-term complications after BDI lens implan-
tation and an approach to improve the outcome, we
retrospectively reviewed the cases of BDI lens
implantation for traumatic aniridia at our institution
by evaluating the difference between the eyes with
and without long-term complications.
METHODS
From January 1999 to December 2007, 43 patients
had BDI lens implantation for traumatic aniridia at
Shandong Eye Institute. However, many of them
were lost to follow-up. Eighteen patients (18 eyes)
who had a follow-up of at least 1 year were included
in this study. They were four women and 14 men,
with a mean age of 22.3 years (range 8e44 years).
All patients had extensive iris defect and complained
of photophobia, glare and blurred vision.
Preoperatively, visual acuity and intraocular
pressure (IOP; Goldmann Applanation Tonometer
Haag-Streit 900; Haag-Streit, Bern, Switzerland)
were examined. A slit-lamp anterior segment eval-
uation, gonioscopy, fundus examination and CEC
count were carried out. The extent of iris defect
was detected. The inclusion criteria for BDI lens
implantation were as follows: best-corrected visual
acuity $0.3 (with the exception of traumatic cata-
ract), CEC density $1500 cells/mm2 and normal
IOP with no intervention.
All operations were performed by the same
surgeon. Informed consent was obtained from the
patients. The procedure of BDI lens implantation
with trans-scleral or sulcus fixation was the same as
that previously described.9 Primary pars plana
vitrectomy (PPV) or extracapsular cataract extrac-
tion was performed following standard protocol
prior to BDI lens implantation if necessary. Two
eyes underwent PPV combined with lens implan-
tation, and 11 had a previous PPV. Intact capsular
membrane was present in three of the 18 eyes to
Br J Ophthalmol 2010;94:456e459. doi:10.1136/bjo.2008.154385
 Clinical science

Br J Ophthalmol: first published as 10.1136/bjo.2008.154385 on 12 April 2010. Downloaded from http://bjo.bmj.com/ on January 8, 2020 at AAO/BJO. Protected by copyright.
Table 1 Preoperative status and surgical procedure in patients with black diaphragm intraocular lens implantation for traumatic aniridia
Visual acuity
Best Intraocular Iris Endothelial
Patient Age spectacle pressure defect cell density Capsule Corneal
no (years) Uncorrected corrected (mm Hg) pattern (cells/mm2) status status Comorbidity Surgical procedure
1 17 0.05 0.9 12 2923 None Transparent Previous PPV Trans-scleral fixation
2 8 FC/20 cm 0.5 11 3115 None Transparent Previous PPV Trans-scleral fixation
3 28 0.05 0.3 15 1821 None Scar Vitreous opacity PPV+trans-scleral fixation
4 14 0.2 0.5 10 2237 None Scar Post-PPV Trans-scleral fixation
5 13 FC/40 cm 0.3 9 2079 None Transparent Vitreous opacity Trans-scleral fixation
6 20 0.12 0.8 15 1941 None Scar Post-PPV Trans-scleral fixation
7 44 FC/40 cm 1.0 16 1838 None Transparent Previous lensectomy, PPV Trans-scleral fixation
8 7 0.05 0.5 12 1916 None Scar Previous PPV Trans-scleral fixation
9 14 0.1 0.5 8 1760 None Scar Previous lensectomy, PPV Trans-scleral fixation
10 13 0.1 0.6 19 2927 None Transparent Previous PKP, PPV Trans-scleral fixation
11 26 FC/20 cm FC/20 cm 13 1517 None Scar Traumatic cataract Lensectomy+PPV+trans-scleral fixation
12 24 0.05 0.4 8 2217 None Scar Aphakic, vitreous opacity Trans-scleral fixation
13 13 0.08 0.3 13 2908 None Scar Previous lensectomy, PPV Trans-scleral fixation
14 46 FC/40 cm 1.0 17 2096 None Transparent Previous lensectomy, PPV Trans-scleral fixation
15 28 FC/30 cm 0.3 11 2192 None Scar Previous lensectomy, PPV Trans-scleral fixation
16 33 0.05 0.5 11 2155 Intact Scar Vitreous opacity Trans-scleral fixation
17 26 FC/40 cm FC/40 cm 8 2840 Intact Scar Traumatic cataract ECCE+IOL sulcus implantation
18 19 0.1 0.1 11 2173 Intact Transparent Traumatic cataract Phaco+IOL sulcus implantation
ECCE, extracapsular cataract extraction; FC, finger counting; IOL, intraocular lens; PKP, penetrating keratoplasty; PPV, pars plana vitrectomy.

support the BDI lens (sulcus implantation in two and trans-
scleral fixation in one). The other 15 lenses were trans-sclerally
fixed. The lens power was calculated according to the SRK II/T
formula. The BDI lenses used in this series were type 67G besides
one 67F and one 67L. Detailed surgical procedures and pre-
existing morbidities are shown in table 1.
The mean follow-up was 41 months (range 12e72 months).
At the end of the follow-up, visual acuity, stereoscopic vision,
IOP and CEC density were recorded. The position of BDI lens
was evaluated by ultrasound biomicroscopy (UBM). The differ-
ence between the eyes with and without long-term complica-
tions was compared.
RESULTS
Photophobia and glare were clearly reduced in all patients
after surgery. Visual acuity was significantly improved. Twelve
eyes did not develop long-term complications, and the visual
results were satisfactory (table 2). Six patients finally lost the
initially recovered vision due to corneal opacity. IOP remained
normal or was controlled within the normal range with medical

Table 2 Postoperative data on patients with black diaphragm intraocular lens implantation for traumatic aniridia
Visual acuity at the final
Visual acuity at 6 months follow-up
Follow-up Best Best Intraocular
Patient period spectacle spectacle Stereoscopic Endothelial cell density pressure Ultrasound biomicroscopy
no (months) Uncorrected corrected Uncorrected corrected vision (cells/mm2) (mm Hg) (haptic position)
1 35 0.6 1.0 0.6 1.0 + 2915 16 Sulcus
2 40 0.7 1.0 0.7 1.0 + 3355 11 Sulcus
3 21 0.2 0.9 0.1 0.8 + 2314 19 NA
4 72 0.2 0.4 0.2 0.4 + 2906 10 Nasal-posterior to sulcus
5 36 0.2 0.4 0.2 0.4
2671 12 NA
6 65 0.2 0.6 0.3 0.9 + 2212 15 Slightly posterior to
ciliary coronal
7 14 0.3 0.8 0.2 1.0 + 2178 16 Sulcus
8 12 0.6 0.8 0.6 0.8
1921 12 NA
9 59 0.4 0.5 0.5 1.0 + 1677 10 Nasal-sulcus;
temporal-ciliary coronal
10 44 0.2 0.8 1.0 1.0 + 1980 (32.35% decrease) 12 Sulcus
11 29 0.1 0.15 0.15 0.2
1002 (29.29% decrease) 14 NA
12 45 0.6 1.0 0.6 0.9
621 (71.99% decrease) 16 NA
13 72 0.5 0.8 FC/20 cm FC/20 cm
Uncountable (corneal opacity) 13 Inferior haptic in front
of iris remnant
14 65 0.3 0.7 FC/10 cm FC/10 cm
Uncountable (corneal opacity) 17 NA
15 24 0.1 0.2 FC/20 cm 0.1
Uncountable (corneal opacity) 36 Temporal-posterior to ciliary
process; nasal-ciliary coronal
16 13 0.3 0.8 FC/10 cm FC/10 cm
Uncountable (corneal opacity) 27 Sulcus
17 32 0.2 1.0 FC/20 cm FC/20 cm
Uncountable (corneal opacity) 25 Sulcus
18 60 0.4 0.6 FC/20 cm FC/20 cm
Uncountable (corneal opacity) 29 Sulcus
FC, finger counting; NA, not available.

Br J Ophthalmol 2010;94:456e459. doi:10.1136/bjo.2008.154385 457

 Clinical science
3000
pre-operative CEC
2000
1000
0 elevation besides direct compression to trabecular mesh. The BDI
group I group II
Figure 1 Preoperative corneal endothelial cell (CEC) number in patients
with stable postoperative CEC number (group I) and those with
postoperative corneal decompensation or CEC loss (group II).
intervention in 14 out of the 18 patients. Refractory glaucoma
occurred in four patients 6e36 months after surgery and could
not be controlled by medication or surgical intervention. The
corneal opacity in six eyes, including the four eyes with refrac-
tory glaucoma, all resulted from corneal decompensation.
Three of the 18 eyes experienced a loss of 30e70% of CECs,
although their corneas were transparent. There was no significant
difference in preoperative CEC number between eyes with post-
operative corneal decompensation or CEC loss and those with
a relatively stable CEC density (p¼0.5266; figure 1). Moreover,
corneal decompensation and CEC loss were not found to be
related to the extent or pattern of iris deficiency. The iris defect
extent was quantified in clock hours. The degree of iris loss was
7.3363.77 clock hours and 9.5062.26 clock hours in patients
without and with long-term complications, respectively
(p¼0.069).
UBM examination showed that the haptics of BDI lens were
located in or slightly posterior to the ciliary sulcus in eyes with
neither secondary glaucoma nor CEC loss (figures 2, 3). Three of
the four secondary glaucoma patients had a normal BDI lens
position with intact capsule membrane (figure 4), and the other
developed endogenous ophthalmitis 4 months after surgery, that
is 2 months before the occurrence of glaucoma, due to long-term
oral immunosuppressants for systemic disease (patient 15). One
of the two patients with corneal decompensation but no glau-
coma was examined by UBM. The inferior haptic was observed
to be in front of the iris remnants and in contact with the cornea
(figure 5).
DISCUSSION
Glaucoma is the most commonly reported complication of BDI
lens implantation, but the mechanism remains unclear. It may
be attributable to the direct compression from the haptics to the
Figure 2 Patient 10. (A) Slit-lamp
image of a well-centred black diaphragm
intraocular lens and transparent graft.
(B) Ultrasound biomicroscopic image of
the lens haptics fixed in the ciliary
coronal (arrows).
458
Br J Ophthalmol: first published as 10.1136/bjo.2008.154385 on 12 April 2010. Downloaded from http://bjo.bmj.com/ on January 8, 2020 at AAO/BJO. Protected by copyright.
trabecular meshwork,10 11 which was indirectly supported by
this study. The haptics of BDI lenses in eyes with no glaucoma
were located in or slightly posterior to the ciliary sulcus, which
limited the contact of haptics with the trabecular meshwork. In
addition, the glaucoma seemed to be latent, occurring 6e36
months after surgery. Interestingly, three of the four refractory
glaucoma eyes had intact capsules, although their lens positions
were normal. In other words, among the 18 eyes, three eyes with
intact lens capsules all developed glaucoma. Therefore, we
suppose that there might be other events involved in IOP
lens is usually heavier than that without the diaphragm. Occa-
sionally, the BDI lens is found to move with some rapid posi-
tional changes of the head or eyes. At this very moment, the
capsule stops the lens from moving backwards, and the anterior
shift might result in transient but frequent friction with the
trabecular mesh and peripheral corneal endothelial cells, causing
damage to the trabecular mesh and eventually leading to a high
IOP. Reinhard et al10 reported glaucoma deterioration and
development in eight of 19 eyes with type 67G BDI lens
implantation for congenital aniridia. They recommended firm
trans-scleral suturing rather than sulcus implantation. We agree
with this, but further investigations are required as to whether to
keep the capsule or to provide a wider space for the BDI lens by
capsulectomy and anterior PPV.
CEC loss and corneal decompensation were also mentioned as
long-term complications of BDI lens implantation,11 but no
investigation of the mechanism was reported. Usually, the causes
of CEC loss and eventual corneal decompensation include
mechanical damage, such as intraocular surgery and contusion,
long-lasting high IOP, iris cyst, anterior uveitis, herpes simplex
virus infection and toxicity of chemical reagents. In the present
study, postoperative inflammation was mild and subsided within
2 weeks following routine medication (data not shown), so we do
not think that the transit postoperative inflammation plays a role
in the occurrence of corneal decompensation. In the six eyes with
corneal decompensation, four are complicated by refractory
glaucoma. For these patients, the main cause might be the friction
of haptics with peripheral corneal endothelial cells (eg, patient 13)
as mentioned above. A high IOP may also exacerbate the CEC
loss. Moreover, the corneal decompensation in patient 14 might
result from endogenous ophthalmitis. In one patient with
a normally positioned BDI lens, the CEC density decreased from
preoperative 2927 cells/mm2 to 1980 cells/mm2 at 44 months
after surgery but still had a transparent cornea, which may be
related to the previous penetrating keratoplasty (patient 10).
In the current study, we first correlated UBM-confirmed
haptic positions with long-term results of BDI lens implanta-
tion. This gave us a hint that a posteriorly situated BDI lens may
shed light on the prevention of complications.
Br J Ophthalmol 2010;94:456e459. doi:10.1136/bjo.2008.154385
 Clinical science

Br J Ophthalmol: first published as 10.1136/bjo.2008.154385 on 12 April 2010. Downloaded from http://bjo.bmj.com/ on January 8, 2020 at AAO/BJO. Protected by copyright.
Figure 3 Patient 13. (A) Slit-lamp
image of corneal opacity due to corneal
decompensation. (B) Ultrasound
biomicroscopic image of the lens haptic
located in front of the remnant iris and in
contact with the cornea (arrow).

Figure 4 Patient 1. (A) Slit-lamp image

of a well-centred black diaphragm
intraocular lens and transparent cornea.
(B) Ultrasound biomicroscopic image of
the lens haptic fixed in the sulcus
(arrow).

Figure 5 Patient 17. (A) Slit-lamp

image of a well-centred black diaphragm
intraocular lens and corneal oedema. (B)
Ultrasound biomicroscopic image of the
lens haptic located in the sulcus (arrow).

In summary, the BDI lens appears to be the best option for
traumatic aniridia due to its favourable visual outcome. How to
completely avoid catastrophic complications remains a chal-
lenge. The long-term outcome can be improved by slight
posterior fixation of the BDI lens in combination with anterior
vitrectomy. Further investigations with more cases are needed.
Acknowledgements We would like to thank P Lin for her editorial assistance.
Funding Supported by the Qingdao Municipal Science and Technology Bureau
(02KGYSH-01).
Competing interests None.
Ethics approval Ethics approval was provided by the Shandong Eye Institute.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES
1. Viestenz A, Küchle M. Retrospective analysis of 417 cases of contusion and rupture
of the globe with frequent avoidable causes of trauma: the Erlangen Ocular Contusion-
Registry (EOCR) 1985e1995. Klin Monatsbl Augenheilkd 2001;218:662e9.
2. Xu J, Wang Y. Epidemiology of eye injury in mainland of China [in Chinese]. Guo Ji Yan
Ke Za Zhi 2004;6:1069e76.
3. Li S. Clinical analysis of related factors on 1226 inpatients with eye injury [in Chinese].
Yan Wai Shang Zhi Ye Yan Bing Za Zhi 2001;23:20e1.
4. Remky A, Redbrake C, Wenzel M. Intrastromal corneal tattooing for iris defects.
J Cataract Refract Surg 1998;24:1285e7.
5. Sundmacher R, Reinhard T, Althaus C. Black-diaphragm intraocular lens for
correction of aniridia. Ophthalmic Surg 1994;25:180e5.
6. Thompson CG, Fawzy K, Bryce IG, et al. Implantation of a black diaphragm intraocular
lens for traumatic aniridia. J Cataract Refract Surg 1999;25:808e13.
7. Beltrame G, Salvetat ML, Chizzolini M, et al. Implantation of a black diaphragm
intraocular lens in ten cases of post-traumatic aniridia. Eur J Ophthalmol
2003;13:62e8.
8. Wong VW, Lam PT, Lai TY, et al. Black diaphragm aniridia intraocular lens for aniridia
and albinism. Graefes Arch Clin Exp Ophthalmol 2005;243:501e4.
9. Dong X, Yu B, Xie L. Black diaphragm intraocular lens implantation in aphakic eyes
with traumatic aniridia and previous pars plana vitrectomy. J Cataract Refract Surg
2003;29:2168e73.
10. Reinhard T, Engelhardt S, Sundmacher R. Black diaphragm aniridia intraocular lens
for congenital aniridia: long-term follow-up. J Cataract Refract Surg
2000;26:375e81.
11. Aslam SA, Wong SC, Ficker LA, et al. Implantation of the black diaphragm intraocular
lens in congenital and traumatic aniridia. Ophthalmology 2008;115:1705e12.
12. Lee S, Kim S, Lee J, et al. Long-term result of black diaphragm intraocular lens
implantation after traumatic anirida. Invest Ophthalmol Vis Sci 2007;48:E-Abstract 3156.

Br J Ophthalmol 2010;94:456e459. doi:10.1136/bjo.2008.154385 459