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Published in final edited form as:

Ophthalmology. 2016 January ; 123(1): 183–190. doi:10.1016/j.ophtha.2015.09.022.

Cataract Surgery Outcomes in Uveitis: The Multicenter Uveitis

Steroid Treatment Trial
H. Nida Sen, MD, MHS1, Francis M. Abreu, BS2, Thomas A. Louis, PhD2, Elizabeth A. Sugar,
PhD2,3, Michael M. Altaweel, MD4, Susan G. Elner, MD5, Janet T. Holbrook, PhD, MPH3,
Douglas A. Jabs, MD, MBA3,6, Rosa Y. Kim, MD7, John H. Kempen, MD, PhD8, and
Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group*
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1National Eye Institute, National Institutes of Health, Bethesda, Maryland 2Department of

Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore,
Maryland 3Department of Epidemiology, The Johns Hopkins University Bloomberg School of
Public Health, Baltimore, Maryland 4Department of Ophthalmology, University of Wisconsin
School of Medicine and Public Health, Madison, Wisconsin 5Department of Ophthalmology,
Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan 6Departments of Ophthalmology
and Medicine, Icahn School of Medicine at Mount Sinai, New York, New York 7Retina Consultants
of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas;
and the Department of Ophthalmology, Weill Cornell Medical College, New York, New York
8Department of Ophthalmology and the Center for Clinical Epidemiology and Biostatistics,

Department of Biostatistics and Epidemiology, The University of Pennsylvania Perelman School of

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Medicine, Philadelphia, Pennsylvania

Abstract
Purpose—To assess the visual outcomes of cataract surgery in eyes that received fluocinolone
acetonide implant or systemic therapy with oral corticosteroids and immunosuppression during the
Multicenter Uveitis Steroid Treatment (MUST) Trial.

Design—Nested prospective cohort study of patients enrolled in a randomized clinical trial.

Participants—Patients that underwent cataract surgery during the first 2 years of follow-up in
the MUST Trial.
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Correspondence: H. Nida Sen, MD, MHS, National Eye Institute, National Institutes of Health, 10 Center Drive, 10N109, Bethesda,
MD 20892. senh@nei.nih.gov.
*A complete listing of the members of the Multicenter Uveitis Steroid Treatment Research Group is available at www.aaojournal.org.
Supplemental material is available at www.aaojournal.org.
Presented at: American Academy of Ophthalmology Annual Meeting, Chicago, IL, October 2014.
Financial Disclosure(s): The author(s) have made the following disclosure(s): D.A.J.: Consultant - Santen (Osaka, Japan); Data and
Safety Monitoring Committee – Applied Genetic Technologies Corporation (Alachua, FL)
J.H.K: Consultant - AbbVie (North Chicago, IL); Alcon (Fort Worth, TX); Allergan (Irvine, CA) Can-Fite (Peta-Tikva, Israel);
Clearside (Alpharetta, GA); Lux Biosciences (Jersey City, NJ); Roche (Basel, Switzerland) Xoma (Berkeley, CA)
Author Contributions: Conception and design: Kempen, Jabs, Abreu, Louis, Sugar, Sen
Analysis and interpretation: Kempen, Jabs, Abreu, Louis, Sugar, Sen
Data collection: Sen, Abreu, Louis, Sugar, Altaweel, Elner, Holbrook, Jabs, Kim, Kempen
Obtained funding: none
Overall responsibility: Kempen, Jabs, Sen
 Sen et al. Page 2

Methods—Visual outcomes of cataract surgery were evaluated 3, 6, and 9 months after surgery
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using logarithmic visual acuity charts. Change in visual acuity over time was assessed using a
mixed-effects model.

Main Outcome Measures—Best-corrected visual acuity.

Results—After excluding eyes that underwent cataract surgery simultaneously with implant
surgery, among the 479 eyes in the MUST Trial, 117 eyes (28 eyes in the systemic, 89 in the
implant group) in 82 patients underwent cataract surgery during the first 2 years of follow-up.
Overall, visual acuity increased by 23 letters from the preoperative visit to the 3-month visit (95%
confidence interval [CI], 17–29 letters; P < 0.001) and was stable through 9 months of follow-up.
Eyes presumed to have a more severe cataract, as measured by inability to grade vitreous haze,
gained an additional 42 letters (95% CI, 34–56 letters; P < 0.001) beyond the 13-letter gain in eyes
that had gradable vitreous haze before surgery (95% CI, 9–18 letters; P < 0.001) 3 months after
surgery, making up for an initial difference of –45 letters at the preoperative visit (95% CI, –56 to
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–34 letters; P < 0.001). Black race, longer time from uveitis onset, and hypotony were associated
with worse preoperative visual acuity (P < 0.05), but did not affect postsurgical recovery (P > 0.05,
test of interaction). After adjusting for other risk factors, there was no significant difference in the
improvement in visual acuity between the 2 treatment groups (implant vs. systemic therapy, 2
letters; 95% CI, –10 to 15 letters; P = 0.70).

Conclusions—Cataract surgery resulted in substantial, sustained, and similar visual acuity

improvement in the eyes of patients with uveitis treated with the fluocinolone acetonide implant or
standard systemic therapy.

Cataract is a common complication of uveitis. It can result from inflammation as part of the
disease process or from the corticosteroids used to treat the inflammation. Cataract surgery
in the setting of uveitis differs from senile cataract and can pose additional challenges and
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risks.1,2 Although the outcomes of cataract surgery in uveitic eyes are not as well studied as
those in nonuveitic eyes, most studies suggest poorer visual outcomes and more
postoperative complications among patients with uveitis. Furthermore, many of these studies
are weighted toward the results of cataract surgery in patients with anterior uveitides.2–6

Preoperative control of inflammation is crucial for cataract surgery in uveitic eyes. A

systematic review of the literature showed that eyes with controlled inflammation at the time
of cataract surgery had better visual outcomes.3 A prospective study showed that eyes with
active inflammation within 3 months before cataract surgery were more likely to have
postoperative macular edema and that a short perioperative course of oral corticosteroids,
started 2 days before surgery, significantly reduced the incidence of postoperative macular
edema.6 Hence, preoperative addition or increase in systemic therapy, mainly
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corticosteroids, has become a standard approach in cataract surgery for uveitic eyes.

An alternative approach to systemic therapy for treating intermediate uveitis, posterior

uveitis, and panuveitis is the fluocinolone acetonide implant (Retisert; Bausch & Lomb,
Rochester, NY), which is designed to provide sustained, steady-state levels of corticosteroids
directly to the eye for up to 3 years. In the Multicenter Uveitis Steroid Treatment (MUST)
Trial, a randomized, clinical effectiveness trial of implant therapy versus standard systemic
therapy with oral corticosteroids and immunosuppression for patients with noninfectious

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 Sen et al. Page 3

intermediate uveitis, posterior uveitis, and panuveitis, both the implant and systemic therapy
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controlled the inflammation in the large majority of patients. Nevertheless, implant therapy
resulted in inactive inflammation in a greater proportion of eyes than did systemic therapy.7
Because cataracts occurred in both treatment groups, the MUST Trial provides the
opportunity to compare the outcomes of cataract surgery in uveitic eyes with fluocinolone
acetonide implants with those of patients treated with systemic corticosteroids and
immunosuppression.

Methods
Eligibility
Patients included in this study were participants in the MUST Trial, a randomized,
comparative effectiveness clinical trial comparing the fluocinolone acetonide intraocular
implant with standard systemic therapy (systemic corticosteroids and immunosuppressive
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medications) for the treatment of noninfectious, recently active intermediate uveitis,

posterior uveitis, or panuveitis (clinicaltrials.gov identifier, NCT00132691). The study
enrolled 255 patients at 23 clinical centers in the United States (21 centers), United
Kingdom, and Australia. The protocol was approved by the institutional review board of
each center, and all participants provided written informed consent. The study complied with
the Health Insurance Portability and Accountability Act and adhered to the tenets of the
Declaration of Helsinki.7,8 Data on best-corrected visual acuity and a detailed ocular and
medical history were collected at 3-month intervals for 2 years.

Uveitic eyes that underwent cataract surgery during follow-up were eligible for inclusion in
this study unless the surgery was performed before or concurrent with implant surgery (Fig
1). Eyes that underwent concurrent cataract and implant surgery were excluded because of
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possible interference of implant surgery and its complications with cataract surgery-related
outcomes. Visit windows were structured for the purpose of this analysis into a preoperative
visit that occurred within 6 months of the date of surgery (−6 to 0 months) and postsurgical
visits that occurred at 3, 6, and 9 months after surgery with windows of 0 to 4 months, 4 to 7
months, and 7 to 10 months, respectively. In addition, eyes that did not have a preoperative
visual acuity measurement or a postsurgical visual acuity measurement within 10 months
after surgery were excluded.

Outcomes
The primary outcome of the current study was best-corrected visual acuity, measured using
logarithmic visual acuity charts8,9 according to a standardized protocol. Secondary outcomes
included binary categorizations of visual acuity patterns. The change from the preoperative
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to the first available postoperative visit was defined in 2 ways. For the purposes of this study,
we considered a 5-letter improvement or more or a visual acuity outcome of 20/40 or better
to be clinically meaningful. We first calculated the proportion of eyes with an improvement
based on the number of letters (5 or 10 letters of improvement), and then the proportion of
eyes that improved to 20/40 or better at the first postoperative visit was analyzed. The
proportion of eyes with visual acuity of 20/40 or better at the first postoperative visit also
was considered.

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Statistical Analyses
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Analyses were conducted based on the treatment being received at the time of the
presurgical visit. The Kruskal-Wallis rank-sum test and the Fisher exact test were used to
compare patient-level characteristics of the 2 therapies for eligible patients at the
preoperative visit. A linear logistic (binary attribute) or multinomial (multicategory attribute)
mixed-effects model with a patient-level random effect to adjust for between-eye correlation
was used to compare preoperative eye-level characteristics between therapies. To model
visual acuity over time, a means mixed-effects model that included terms for treatment, visit,
and treatment-by-visit interaction was specified and estimated via maximum likelihood. A
patient-level random intercept and a first-order autoregressive covariance structure for the
within-eye repeated measurements were included to introduce between-eye correlation (via
the random intercept) and longitudinal within-eye correlation (the first-order autoregressive
component).
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The association of other risk factors was assessed by adding them to the base model
structure as follows: a main effect to assess the impact on baseline visual acuity and an
interaction term with time to assess the impact on change in visual acuity after surgery.
Secondary outcomes were modeled by logistic regression estimated via generalized
estimating equations that account for the between-eye correlation for individuals with
bilateral cataract surgery. Inability to grade vitreous haze was used as a surrogate for cataract
severity. The risk factors considered included both individual characteristics (age, race,
gender, uveitis location, presence of systemic disease) and preoperative eye-specific
characteristics (disease duration, intraocular pressure, inability to grade vitreous haze).
Robust standard errors were computed for all models. Statistical analyses were performed
using SAS software version 9.3 (SAS Inc, Cary, NC), Stata 12 software (StataCorp LP,
College Station, TX), and R software version 3.0.1 (The R project for Statistical Computing;
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available at: http://www.r-project.org/).

Results
From the 479 eyes with uveitis of the 255 individuals enrolled in the MUST Trial, a total of
117 eyes from 82 patients met the criteria for inclusion in the cataract study during the first 2
years of follow-up in the MUST Trial (Fig 1). A total of 28 eyes (24%) received systemic
therapy and 89 eyes (76%) received implant therapy. Two eyes receiving systemic therapy
and 15 of those receiving implant therapy originally were randomized to receive the other
treatment. The most common reasons for exclusion included aphakia or pseudophakia at
enrollment (n = 202 eyes), no surgery during follow-up (n = 113), or concurrent cataract and
implant surgery (n = 22).
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Demographic characteristics at the preoperative visit were similar between treatment groups,
with 33% of patients being men, 18% of patients being black, and a median age of 46 years
overall (Table 1). Fifty-two patients (63%) had posterior uveitis or panuveitis, with a
nonsignificantly higher proportion in the implant group (67%) compared with the systemic
group (55%). Preoperative visit visual acuities for eyes in the implant group were better than
those in the systemic therapy group (median, 60 vs. 43 letters, respectively; P = 0.090), but
this difference did not achieve conventional statistical significance. However, the proportion

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of eyes with visual acuity worse than 20/100 was significantly higher in the systemic group
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than in the implant group (64% vs. 36%, respectively; P = 0.031). Time since uveitis onset
(or duration of uveitis) was similar between the 2 treatment groups, with an overall median
of 2 years (interquartile range, 1–5 years). The proportion of eyes with ungradable vitreous
haze at the preoperative visit was significantly higher in the systemic treatment group (43%
vs. 16%; P = 0.003; Table 1). Preoperative intraocular pressure was within the normal range
in both groups, but the median was 2-mmHg higher for eyes in the implant group, a
magnitude that was statistically significant (P = 0.037), but not clinically meaningful.

Cataract surgery included intraocular lens placement in the overwhelming majority of eyes
(113 eyes [97%]); the other 4 eyes (3%) were left aphakic. There was no difference by
treatment group. In the implant group, 86 eyes (97%) had an intraocular lens placed, and in
the systemic therapy group, 27 eyes (96%) had an intraocular lens placed (P = 0.91).
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Overall, visual acuity improved by 23 letters (95% confidence interval [CI], 18–29 letters; P
< 0.001) from the preoperative visit to the 3-month postoperative visit. The visual acuity was
stable thereafter with an additional 2 letters at 6 months (95% CI, −0 to 4 letters; P = 0.05)
that vanished by 9 months (P = 0.62). This pattern of improvement at 3 months that
remained stable through 9 months was seen in both treatment groups (Fig 2). The point
estimate of improvement was larger for eyes receiving systemic therapy (29 letters; 95% CI,
17–43 letters; P < 0.001) as compared with eyes receiving implant therapy (21 letters; 95%
CI, 16–27 letters; P < 0.001). However, the difference between the groups in visual
improvement was not statistically significant (mean, −9 letters for implant vs. systemic
therapy; 95% CI, −23 to 6 letters; P = 0.24).

In the multivariate model, a number of factors were associated with worse visual acuity at
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the preoperative visit (Table 2). Eyes that had ungradable preoperative vitreous haze had a
preoperative visual acuity that was 45 letters worse (−45 letters) than in eyes that were
gradable (95% CI, −56 to −34 letters; P < 0.0001); eyes of black patients had a preoperative
visual acuity that was 12 letters worse than those of nonblack patients (95% CI, −22 to −2
letters; P = 0.021), and preoperative hypotony (intraocular pressure, ≤7 mmHg) was
associated with a visual acuity of 8 letters worse as compared with eyes with normal
intraocular pressure (8–23 mmHg). For each decade since uveitis diagnosis, there was a 4.7-
letter worse preoperative visual acuity (95% CI, −9 to −0.4 letters; P = 0.033). After
adjusting for other risk factors, there was no significant difference in the preoperative visual
acuity for the 2 treatment groups (implant vs. systemic therapy: median, 6 letters; 95% CI,
−4 to 15 letters; P = 0.22).

Only the ability to grade preoperative vitreous haze was associated significantly with the
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amount of improvement in visual acuity after cataract surgery (Table 2). For eyes with
gradable vitreous haze, visual acuity improved by a mean of 13 letters from the preoperative
visit to the 3-month postoperative visit (95% CI, 9–18 letters; P < 0.001) and showed a
significant additional gain at 6 months (mean, 3 letters; 95% CI, 1–4 letters; P = 0.001) that
had vanished by 9 months (P = 0.52). Eyes that were not gradable for vitreous haze at the
preoperative visit had an additional mean improvement of 42 letters (95% CI, 35 to −56
letters; P < 0.001) from the preoperative visit to the 3-month postoperative visit beyond that

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observed with gradable vitreous haze, for a mean total improvement of 55 letters. The
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difference in improvement was such that eyes with preoperative ungradable vitreous haze
had postoperative visual acuities that were not statistically or clinically significantly
different from those with gradable preoperative vitreous haze (mean, −3 letters; 95% CI, −12
to 7 letters; P = 0.55). After adjusting for other risk factors, there was no significant
difference in the improvement in visual acuity between the 2 treatment groups (implant vs.
systemic therapy: mean, 2 letters; 95% CI, −10 to 15 letters; P = 0.70).

Overall, most eyes improved by a clinically meaningful amount between the preoperative
and first postoperative visit (Table 3). Ninety-two eyes (79%) had an improvement of 5
letters or more and 77 eyes (67%) had an improvement of 10 letters or more. In fact, 72 eyes
(62%) had a postoperative visual acuity of 20/40 or better, including 45 eyes (63%) that
improved from worse than 20/40 to 20/40 or better, all of whom had at least a 5-letter gain.
Very few eyes experienced a 5-letter or more decline in visual acuity; 5 eyes (4%) had a
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decline of 5 letters or more and only 3 eyes (3%) had a decline of 10 letters or more.

Similar to what was seen in the analysis of mean change in visual acuity, eyes with
ungradable vitreous haze at the preoperative visit were more likely to experience
postoperative visual acuity improvement by 10 letters or more (odds ratio [OR], 7.9 letters;
95% CI, 1.8–35.1 letters; P = 0.007) and a postoperative visual acuity of 20/40 or better
regardless of preoperative visual acuity (OR, 1.7 letters; 95% CI, 1.1–2.7 letters; P = 0.03).
There was no significant difference in the probability of postoperative improvement in
vision by 5 letters or more, 10 letters or more, or having postoperative visual acuity of 20/40
or better for the 2 treatment groups (P > 0.49; Table 3). None of the other patient or eye
characteristics were associated significantly with any of the postoperative improvement
outcomes. However, there was a suggestion that having posterior uveitis or panuveitis at
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enrollment in the MUST Trial was associated with a lower probability of a 5- or 10-letter
improvement (OR, 0.3; 95% CI, 0.1–1.1; P = 0.060; and OR, 0.4; 95% CI, 0.2–1.1; P = 0.07,
respectively). Because of the small number of eyes with a decline, we were unable to
evaluate risk factors associated with a loss of vision.

Discussion
Cataract is among the most common structural complications of uveitis and its treatment
with corticosteroids, and cataract surgery is among the most common surgical procedures
performed on patients with uveitis. Several studies have reported that substantial visual gain
occurs in most uveitic eyes after cataract surgery.2–4,10–14 Although cataract is a well-
recognized occurrence with the fluocinolone acetonide implant and cataract surgery is
needed in more than 90% of eyes by 3 years after implantation,15 the MUST Trial provided
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the first opportunity to compare the outcomes of cataract surgery in eyes with the implant
with those of patients treated with systemic therapy. The current study showed statistically
significant, clinically meaningful, and sustained (for up to 9 months after surgery)
improvement in visual acuity of similar magnitude after cataract surgery in both eyes treated
with systemic therapy and those treated with the fluocinolone acetonide implant. Overall,
62% of eyes achieved a visual acuity of 20/40 or better after surgery. This success proportion

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is lower than that reported for uncomplicated cataract surgery in the general public (96%),16
but similar to that reported in other studies of uveitic cataract surgery.3
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In a meta-analysis of the outcomes of cataract surgery, Mehta et al3 estimated that the
overall percent of eyes with uveitis achieving 20/40 or better postoperative visual acuity was
68% and that anterior approaches, intraocular lens placement, nonsilicone lenses, and
operating on eyes with inactive uveitis were associated with better outcomes. Uveitis class
was not evaluated systematically, but Fuchs heterochromic uveitis seemed to respond better
than other types of uveitis; intermediate uveitis seemed to have a similar success rate to the
overall rate; and the one panuveitis evaluated, Behçet's disease, had worse outcomes. In this
regard, there was a suggestion from our data that posterior uveitis and panuveitis may show
a worse response than intermediate uveitis. Such a result would not be surprising because
patients with posterior uveitis are more likely to encounter permanent structural damage that
may limit visual improvement. Because the MUST Trial enrolled patients with only
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intermediate uveitis, posterior uveitis, or panuveitis, its results ay not be comparable directly
with those of series including eyes with anterior uveitis. Nevertheless, the proportion of eyes
with a postoperative visual acuity of 20/40 or better in the MUST Trial is on the same order
as that in the meta-analysis.

The level of vision before cataract surgery differed between the 2 treatment groups, and it
was likely that eyes in the systemic group had worse cataracts at the time of surgery. Eyes
receiving systemic therapy were significantly more likely to have a preoperative visual
acuity worse than 20/100 and, assuming that inability to grade the vitreous haze is a marker
for denser cataract, worse cataracts. Reasons for this difference are unknown, but it is
possible that ophthalmologists were likely to operate sooner on eyes treated with implant
therapy because cataract surgery is an expected and nearly universal complication of implant
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therapy.7,15,17 It is also possible that eyes with more severe cataracts in the implant group
had simultaneous cataract and implant surgery and were excluded from this study.
Nevertheless, there was no significant difference in the visual improvement between the 2
treatment groups, even after adjusting for other risk factors.

Sheppard et al17 evaluated cataract outcomes in uveitic eyes that received the fluocinolone
acetonide implant and compared them with those of fellow, nonimplanted eyes. They
reported that eyes undergoing cataract surgery after the implantation had a better visual
acuity gain and less postoperative inflammation than the fellow eyes, which were untreated
or managed with regional corticosteroid injections.15 No details were given in this article
about the duration of inactive disease or preoperative regimens in the nonimplant group,
whereas given the duration of effect of the implant, these eyes were receiving preoperative
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corticosteroid therapy comparable with that resulting from systemic therapy. In this regard,
the MUST results suggest that eyes with intermediate uveitis, posterior uveitis, or panuveitis
will have similar postoperative visual improvement whether the eye has been treated with an
implant or with systemic therapy.

Although black patients and eyes with hypotony were associated with poorer preoperative
visual acuity, they were not associated with any worse likelihood of visual improvement
after cataract surgery. The risk factors that were associated with lower preoperative visual

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acuity (black race, disease duration, hypotony) are known risk factors for poorer visual
acuity in eyes with uveitis.18–20 Longer disease duration is known to be associated with
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poorer outcomes and more structural complications,18,21,22 and hypotony, which likely is
reflective of the chronicity and severity of the underlying disease, has been associated with
poorer visual acuity in patients with uveitis.19,21,22 Although these factors were associated
with poorer overall vision, none of them had an impact on improvement in visual acuity
after surgery (P > 0.05, test of interaction). The only characteristic associated with better
gains in vision after surgery was ungradable vitreous haze before surgery. As noted above, it
is likely that ungradable vitreous haze before surgery was a marker for denser and worse
cataract, resulting in worse visual acuity before surgery and bigger gains in acuity at the
postoperative visits.

The typical recommendation is to defer cataract surgery in uveitic eyes until the uveitis has
been inactive for a minimum of 3 months before surgery and to pretreat patients with
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systemic corticosteroids briefly before cataract surgery and for a short time after surgery. A
systematic review and meta-analysis of the literature found that active uveitis at the time of
cataract surgery was associated with poorer outcomes. A prospective study of cataract
surgery6 demonstrated that active uveitis within 3 months before cataract surgery and failure
to use perioperative systemic corticosteroids each were associated with worse outcomes and
evidenced by more macular edema. Unfortunately, the follow-up schedule and visit windows
in this study (in which the preoperative visit could be as much as 6 months before surgery)
precluded the evaluation of the effect of inactive uveitis in the 3 months before surgery.
Similarly, the surgical data collection did not include information on the use of perioperative
oral corticosteroids.

Our study is limited by the relatively small number of eyes in the systemic treatment group.
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We were unable to measure the severity of cataract directly and instead used a surrogate
(inability to grade vitreous haze) to attempt to account for the impact of severity. The large
majority of eyes showed an improvement in visual acuity, which limited our ability to
perform multivariate analyses of risk factors related to visual acuity threshold. Nearly all
eyes had placement of an intraocular lens, limiting any power to evaluate the effect of
aphakia. Finally, the small number of eyes with a decline made it impossible to evaluate for
risk factors related to decline. Nevertheless, our study suggested that patients with
intermediate uveitis, posterior uveitis, or panuveitis show similar improvements in visual
acuity after cataract surgery, regardless whether the uveitis was treated with the fluocinolone
acetonide implant or with systemic therapy with oral corticosteroids and
immunosuppression.
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Supplementary Material
Refer to Web version on PubMed Central for supplementary material.

Acknowledgments
Supported by the National Eye Institute, National Institutes of Health, Bethesda, Maryland (Collaborative
Agreement nos.: U10EY014655 [D.A.J.], U10EY014660 [J.T.H.], and U10EY014656 [M.M.A.]); and the National
Eye Institute Intramural Research Program (H.N.S.) (Bethesda, MD). Bausch & Lomb (Rochester, NY) provided

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support to the study in the form of donation of fluocinolone implants for patients randomized to implant therapy
who were uninsured or otherwise unable to pay for implants, or who were located at a site where implants could not
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be purchased (e.g., the United Kingdom). Additional support was provided by Research to Prevent Blindness, Inc.,
New York, NY; the Paul and Evanina Mackall Foundation (Chicago, IL); and the Lois Pope Life Foundation
(Delray Beach, FL). A representative of the National Eye Institute participated in the conduct of the study, including
the study design; collection, management, analysis, and interpretation of the data; and review and approval of this
manuscript. The sponsor or funding organization had no role in the design or conduct of this research.

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acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008:1261191–201.

16. Powe NR, Schein OD, Gieser SC, et al. Synthesis of the literature on visual acuity and
complications following cataract extraction with intraocular lens implantation Cataract Patient
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17. Sheppard JD Jr, Nguyen QD, Usner DW, Comstock TL. Post-cataract outcomes in patients with
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Abbreviations and Acronyms

CI confidence interval

IQR Interquartile range

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MUST Multicenter Uveitis Steroid Treatment

OR odds ratio
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Figure 1.
Flowchart showing the selection of uveitic eyes with cataract surgery during the Multicenter
Steroid Treatment Trial for inclusion in analysis. VA = visual acuity.
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Figure 2.
Mean visual acuity over time for eyes with cataract surgery during the Multicenter Steroid
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Treatment Trial stratified by treatment (implant [grey] vs. systemic [black] therapy). The
95% confidence intervals are included for each treatment group at each interval.
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Table 1
Characteristics of Patients and Eyes Undergoing Cataract Surgery in the Multicenter
Uveitis Steroid Treatment Trial
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Treatment Group

Overall Systemic Implant P Value*

Patient characteristics
Participants, no. (%) 82 22 (27) 60 (73)
Demographics
Age at preoperative visit (yrs), median (IQR) 46 (31–53) 53 (38–58) 44 (31–51) 0.20
Male gender, no. (%) 27 (33) 5 (23) 22 (37) 0.29
Black race, no. (%) 15 (18) 3 (14) 12 (20) 0.75
Clinical characteristics at the time of randomization in the MUST Trial
Posterior uveitis or panuveitis, no. (%) 52 (63) 12 (55) 40 (67) 0.44
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Systemic disease, no. (%) 22 (27) 4 (18) 18 (30) 0.40

Eye characteristics
Eligible eyes, no. (%) 117 28 (24) 89 (76)

Time since uveitis onset at the preoperative visit (yrs),‡ median (IQR)† 2 (1–5) 1 (0–3) 2 (1–5) 0.18‡
Preoperative visual acuity (standard letters), no. (%)
Median (IQR) 56 (25–69) 43 (5–59) 60 (38–72) 0.09
20/40 or better 29 (25) 5 (18) 24 (27) 0.33
Worse than 20/100 50 (43) 18 (64) 32 (36) 0.031
20/200 or worse 33 (28) 12 (43) 21 (24) 0.09
Preoperative vitreous haze ungradable, no. (%) 26 (22) 12 (43) 14 (16) 0.003

Preoperative intraocular pressure (mmHg), no. (%)†

Median (IQR) 18 (14–23) 16 (13–20) 18 (15–24) 0.037
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≤7 5 (4) 3 (11) 2 (2)

8–23 84 (72) 21 (75) 63 (72)
24–29 19 (16) 2 (7) 17 (19)
≥30 8 (7) 2 (7) 6 (7)

IQR = interquartile range (i.e. the 25th to 75th percentile); MUST = Multicenter Uveitis Steroid Treatment.
*
Unless otherwise specified, P values compare the distribution of all primary categories excluding missing values.
†
Missing values: 1 preoperative intraocular pressure observation missing (1%) from implant group, and 2 observations missing time since uveitis at
the preoperative visit in the implant group (2%).
‡
Based on a log transformation of time since uveitis onset at the preoperative visit.
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Table 2
Adjusted* Risk Factors Affecting Visual Acuity at the Preoperative Visit and Affecting the
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Preoperative to Postoperative Visit Change in Visual Acuity in the Multicenter Uveitis

Steroid Treatment Trial

Preoperative Visual Acuity

Estimated Mean Difference at Preoperative Visit, Letters (95% Confidence

Characteristics Interval) P Value
Treatment
Systemic Reference
Implant 5.5 −3.3 to 14.4 0.22
Race
Nonblack Reference
Black −12.0 −22.1 to −1.8 0.021
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Time from uveitis onset at preoperative visit (10 −4.7 −9.0 to −0.4 0.033
yrs), centered at 2 yrs
Preoperative intraocular pressure (mmHg)
≤7 −7.6 −14.0 to −1.0 0.022
8–23 Reference
24–29 −5.6 −16.4 to 5.2 0.31
≤30 9.1 −1.6 to 19.8 0.096

Change from Preoperative to Postoperative Visual Acuity

Mean Difference from Preoperative to Postoperative Visits, Letters (95%

Confidence Interval) P Value

Eyes with gradable preoperative vitreous haze†

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Preoperative visit Reference

3 mos 13.4 9.7–17.1 <0.001
6 mos 15.9 12.6–19.2 <0.001
9 mos 15.4 11.7–19.0 <0.001
Eyes with ungradable preoperative vitreous haze
Preoperative visit Reference
3 mos 55.4 42.9–67.9 <0.001
6 mos 58.0 45.4–70.6 <0.001
9 mos 57.4 44.7–70.1 <0.001

*
Adjusted for all factors simultaneously.
†
The association of preoperative vitreous haze with preoperative visual acuity was significantly different from its association with postoperative
visual acuity (P < 0.001).
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Table 3
Risk Factors for Visual Acuity Improvement in Eyes Undergoing Cataract Surgery in the Multicenter Uveitis Steroid Treatment Trial
Sen et al.

Postoperative Visual Acuity 20/40 or Better (n =

≥5-Letter Improvement (n = 117) ≥10-Letter Improvement (n = 115)* 117)

Odds Ratio 95% Confidence Interval P Value Odds Ratio 95% Confidence Interval P Value Odds Ratio 95% Confidence Interval P Value
Patient characteristics
Demographics
Age at preoperative visit (yrs) 1.0 0.9–1.1 0.47 1.0 0.9–1.1 0.19 1.0 0.9–1.1 0.13
Gender
Female Ref Ref Ref
Male 1.2 0.4–3.1 0.76 0.9 0.4–2.1 0.79 1.7 0.7–4.1 0.24
Race
Nonblack Ref Ref Ref
Black 0.9 0.3–2.8 0.82 1.3 0.4–4.0 0.59 0.7 0.3–2.1 0.57
Clinical characteristics at the
time of randomization in the
MUST Trial
Uveitis class
Intermediate uveitis Ref Ref Ref
Posterior uveitis or 0.3 0.1–1.1 0.06 0.4 0.2–1.1 0.07 1.0 0.4–2.4 0.98
panuveitis
Systemic disease
No Ref Ref
Yes 1.0 0.3–2.8 0.96 1.0 0.4–2.6 0.97 1.6 0.6–4.1 0.34

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Eye characteristics
Treatment
Systemic Ref Ref Ref
Implant 1.4 0.5–4.0 0.49 1.0 0.5–2.5 0.99 1.36 0.6–3.3 0.49
Time from uveitis onset at 1.0 0.9–1.1 0.96 1.0 0.9–1.1 0.91 1.0 0.9–1.1 0.36
preoperative visit (yrs), centered
at 2 yrs
Preoperative intraocular
pressure (mmHg)
≤7 1.3 0.1–14.2 0.80 2.3 0.2–22.4 0.47 0.2 0.0–1.3 0.09
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Postoperative Visual Acuity 20/40 or Better (n =

≥5-Letter Improvement (n = 117) ≥10-Letter Improvement (n = 115)* 117)

Odds Ratio 95% Confidence Interval P Value Odds Ratio 95% Confidence Interval P Value Odds Ratio 95% Confidence Interval P Value
Sen et al.

8–23 Ref Ref Ref

24–29 1.4 0.4–5.4 0.62 1.5 0.5–4.6 0.51 1.1 0.4–3.3 0.80
≥30 0.7 0.1–4.0 0.74 1.2 0.2–6.3 0.86 0.9 0.2–4.2 0.93
Preoperative vitreous haze
Gradable Ref Ref Ref
Ungradable 3.7 0.8–16.7 0.08 7.9 1.8–35.1 0.007 1.7 1.1–2.7 0.03

MUST = Multicenter Uveitis Steroid Treatment; Ref = reference.

*
Two eyes with a preoperative visual acuity of 89 letters, which precluded a 10-letter improvement, were excluded.

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