223

ARTICLE

Comparison of prednisolone acetate 1.0%

and difluprednate ophthalmic emulsion
0.05% after cataract surgery: Incidence
of postoperative steroid-induced ocular
hypertension
Marius A. Tijunelis, MD, MBA, Erica Person, MD, MS, Leslie M. Niziol, MS, David C. Musch, PhD, MPH,
Paul Ernest, MD, Madeline McBain, Shahzad I. Mian, MD

Purpose: To compare intraocular pressure (IOP) outcomes be-
tween 2 common, commercially available corticosteroid drops: di-
fluprednate ophthalmic emulsion 0.05% and prednisolone acetate
1.0%.
Setting: TLC Eyecare and Laser Centers, Jackson, Michigan,
USA.
Design: Retrospective chart review.
Methods: The outcomes of consecutive patients who had un-
eventful cataract surgery from April 2013 to September 2013 and
used prednisolone acetate postoperatively were compared with
the outcomes of consecutive patients who had uneventful cataract
surgery from June 2014 to October 2014 and used difluprednate
postoperatively.
Results: The study included 224 eyes treated with prednisolone
acetate 4 times daily for 30 days and 225 eyes treated with
difluprednate 2 times daily for 30 days. There was no significant dif-
ference between the 2 groups in age, sex, or race. In addition, the
mean IOP did not differ significantly between the prednisolone ac-
etate group and the difluprednate group at the preoperative mea-
surement or 1 month after surgery, nor was there a difference in
the 1-month change in IOP between groups. No association was
found between the incidence of a 6 mm Hg or higher increase in
IOP 1 month after surgery and steroid treatment. One month
postoperatively, 4 eyes in the prednisolone acetate group and 5
eyes in the difluprednate group had an IOP higher than 21 mm Hg.
Conclusions: There was no significant difference in the mean
IOP or percentages showing IOP elevation between eyes treated
with difluprednate and eyes treated with prednisolone acetate after
cataract surgery. This was likely the result of low-frequency dosing
and short duration of steroid use.
J Cataract Refract Surg 2017; 43:223–227 Q 2017 ASCRS and ESCRS

O
ver the past several decades, topical steroids such
as prednisolone acetate 1.0% have been commonly
used to treat postoperative inflammation after
ophthalmic surgery. In June 2008, the U.S. Food and
Drug Administration (FDA) approved a potent new ste-
roidddifluprednate ophthalmic emulsion 0.05% (Dure-
zol)dfor the treatment of postoperative inflammation
and pain. Difluprednate (difluoroprednisolone butyrate
acetate) is a prednisolone derivative that was modified to
increase its potency. The molecule was fluorinated at the
C-6 and C-9 positions, and a butyrate ester was added
to the C-17 position. The combination of these changes
resulted in an increase in affinity for the glucocorticoid re-
ceptor. In addition, an acetate ester was added at position
C-21 to enhance tissue penetration, which allows more of
the active drug to reach the uvea. These modifications
resulted in a drug with an active metabolite that is 56 times
stronger than prednisolone.1
Smith et al.2 found that difluprednate administered
twice daily, when started 24 hours before cataract
surgery, resulted in significantly decreased postoperative
inflammation. Donnenfeld et al.3 found that after cataract

Submitted: August 17, 2016 | Final revision submitted: November 28, 2016 | Accepted: December 2, 2016
From the Department of Ophthalmology and Visual Sciences (Tijunelis, Niziol, Musch, Mian) and the Department of Epidemiology (Niziol, Musch), W.K. Kellogg Eye
Center, University of Michigan, Ann Arbor, TLC Eyecare and Laser Centers (Person, Ernest), Jackson, and the Michigan State University (McBain), East Lansing,
Michigan, USA.
Corresponding author: Shahzad I. Mian, MD, Department of Ophthalmology and Visual Sciences, W.K. Kellogg Eye Center, University of Michigan, 1000 Wall Street, Ann
Arbor, Michigan 48105, USA. E-mail: smian@umich.edu.

Q 2017 ASCRS and ESCRS 0886-3350/$ - see frontmatter

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224 COMPARISON OF 2 STEROID EYEDROPS AFTER CATARACT SURGERY
surgery, difluprednate in a high-dose pulsed-therapy regi-
ment resulted in reduced inflammation and a more rapid
return of vision than prednisolone acetate.
Because difluprednate has such high potency and steroids
have known associations with intraocular pressure (IOP)
elevation, there is concern that its use could result in glau-
comatous optic neuropathy if elevated IOP is left untreated.
Because of vigilant postoperative preventive measures, the
reported incidence of this complication is low; however,
approximately 8% of patients have a corticosteroid-
induced IOP elevation after cataract surgery.3
In 2014, Jeng et al.4 performed a retrospective chart re-
view and concluded that eyes treated with difluprednate af-
ter vitreoretinal surgery were at an increased risk for
developing a clinically significant increase in IOP than
eyes treated with prednisolone acetate. We sought to deter-
mine whether there was a significantly greater incidence of
corticosteroid-induced IOP response in eyes treated with
difluprednate or eyes treated with prednisolone acetate
for postoperative inflammation after cataract surgery.
PATIENTS AND METHODS
Study Cohort and Patient Enrollment
After the University of Michigan Institutional Review Board
deemed this study to be not regulated, a retrospective medical re-
cord review of consecutive patients who had routine primary cata-
ract extraction by 1 of 2 surgeons (E.P., P.E.) was performed.
Two cohorts were identified. The first cohort included patients
who had cataract surgery from April 2013 through September
2013 and were treated postoperatively with prednisolone acetate
4 times a day for 30 days, nepafenac (Nevanac) 0.1% 3 times a
day for 30 days, and ofloxacin 0.3% 4 times a day for 7 days.
The second cohort included patients who had cataract surgery
from June through October 2014 and were treated postoperatively
with difluprednate 2 times a day for 30 days, nepafenac (Ilevro)
0.3% once a day for 30 days, and ofloxacin 0.3% 4 times a day
for 7 days. Neither prednisolone acetate nor difluprednate was
weaned over the 30-day administration period.
The data collected from the medical record review included age at
the preoperative visit, sex, race, history of glaucoma, immunosup-
pression status, history of diabetes mellitus, preoperative IOP (the
IOP measured at the preoperative cataract evaluation), IOP 1 day
and 1 month postoperatively, and the type of tonometry used. To
obtain IOP measurements, a Tono-Pen (Reichert Technologies),
which is a handheld applanation tonometer, or a Goldmann appla-
nation tonometer, which is a mounted tonometer, was used.
Consecutive patients aged 18 years or older, who had uneventful
cataract surgery, were identified. The exclusion criteria included
patients with a planned combined or complicated procedure (eg,
hypermature cataract), patients who were comanaged by a referring
optometrist who was outside of the TLC Eyecare and Laser Center
provider network with incomplete data, and patients who had pre-
vious glaucoma surgeries including trabeculectomy or tube shunt
placement.
Data from Jeng et al.4 were used to estimate the sample size
necessary to power this study adequately. Based on the premise
that 20% of eyes treated with prednisolone acetate and 35% of
eyes treated with difluprednate would develop an IOP spike, 151
eyes in each cohort would be required (using a 2-tailed test) to pro-
vide adequate error protection (Type 1 and II error probabilities of
0.05 and 0.20, respectively).
Main Outcome Measures
The measures used to determine the primary outcomes were the
incidence of an increase in IOP higher than 6 mm Hg from the
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preoperative IOP (measured at the preoperative cataract evalua-
tion) or an IOP higher than 21 mm Hg 1 month postoperatively.
Data Acquisition and Analysis
Characteristics of the sample were assessed with descriptive statis-
tics, including means G SD for continuous measures and fre-
quencies and percentages for categorical measures, and stratified
by steroid treatment group. Differences between the 2 treatment
groups were assessed with 2-sample t tests and chi-square or
Fisher exact tests for person-based measures. The IOP outcomes
were compared between steroid treatment groups with linear
mixed regression (for continuous IOP) and repeated measures lo-
gistic regression models (for threshold levels of IOP or IOP
change). These models accounted for the correlation between
the eyes of the same patient. The IOP thresholds were an increase
in IOP higher than 6 mm Hg from baseline and an IOP higher
than 21 mm Hg 1 month postoperatively. Statistical Analysis Soft-
ware (version 9.4, SAS Institute, Inc.) was used for all statistical
analyses.
RESULTS
The study assessed 243 patient records, including 123 pa-
tients (225 eyes) in the difluprednate cohort and 120 pa-
tients (224 eyes) in the prednisolone acetate cohort.
Table 1 shows the demographics by postoperative treat-
ment group. There were no statistically significant differ-
ences between the 2 groups based on age (prednisolone
acetate group 68.1 G 11.4 years, range 33 to 86; diflupred-
nate groups 67.1 G 11.3 years, range 35 to 92)
(P Z .4935). There was also no statistically significant dif-
ference between the 2 groups in sex, race, diabetes status,
glaucoma status, or systemic steroid/immunosuppressant
use.
The preoperative IOP was similar between eyes treated
postoperatively with difluprednate (15.4 G 2.9 mm Hg)
and eyes treated postoperatively with prednisolone acetate
(14.8 G 3.4 mm Hg) (P Z .0626). One month postopera-
tively, there was no statistically significant difference in the
mean IOP between the prednisolone acetate group
(14.3 G 3.4 mm Hg) and the difluprednate group
(14.5 G 3.6 mm Hg) (P Z .6582). The change in IOP
from baseline to 1 month postoperatively also was not
significantly different between the 2 groups (P Z .2803).
Table 2 and Figure 1 show the IOP measurements between
the groups. From baseline to 1 month postoperatively, 12
eyes (5.4%) in the prednisolone acetate group and 6 eyes
(2.7%) in the difluprednate group had an IOP increase
that was higher than 6 mm Hg (P Z .1975), whereas 4
eyes (1.8%) in the prednisolone acetate group and 5 eyes
(2.2%) in the difluprednate group had an IOP increase
higher than 21 mm Hg (P Z .8209).
Of the 6 eyes that were treated with difluprednate and
had an IOP increase higher that 6 mm Hg from baseline,
1 eye had an IOP of 35 mm Hg 1 month postoperatively.
One day postoperatively, this patient was treated with a
short course of brimonidine but was no longer on topical
glaucoma treatment 1 month postoperatively. The patient
was ultimately diagnosed as a steroid responder. Another
patient with a preexisting diagnosis of severe-stage primary
open-angle glaucoma, who was using 4 topical glaucoma
 COMPARISON OF 2 STEROID EYEDROPS AFTER CATARACT SURGERY 225

Table 1. Patient demographics.

Number (%)

Parameter Difluprednate 0.05% Prednisolone Acetate 1% P Value

Sex
Male 51 (41.5) 57 (47.5) .3437
Female 72 (58.5) 63 (52.5)
Race
White 113 (91.9) 104 (88.1) .5608
Black 6 (4.9) 10 (8.5)
Other 4 (3.3) 4 (3.4)
Diabetes
None 84 (68.3) 80 (66.7) .7828
Type 1 2 (1.6) 4 (3.3)
Type 2 37 (30.1) 36 (30.0)
Glaucoma
None 107 (87) 93 (77.5) .1474
Glaucoma suspect/POAG 12 (9.8) 19 (15.8)
PACG 4 (3.3) 8 (6.7)
Systemic steroid/immunosuppressant
None 118 (95.9) 113 (94.2) .6513
Prednisone 5 (4.1) 6 (5.0)
Mycophenolate mofetilt 0 1 (0.8)

PACG Z primary angle-closure glaucoma; POAG Z primary open-angle glaucoma.

medications before cataract surgery in both eyes, developed
an increase in IOP 1 month postoperatively. This patient
was on no additional glaucoma treatment during postoper-
ative recovery. The remaining 3 eyes did not have a known
history of ocular hypertension, glaucoma suspect, or glau-
coma. Another 15 eyes treated with topical glaucoma med-
ications preoperatively and 5 eyes treated for less than
1 week postoperatively with a topical glaucoma medication
did not develop a steroid response 1 month postoperatively.
Of the 12 eyes that were treated postoperatively with
prednisolone acetate and had an IOP increase higher than
6 mm Hg from baseline, 1 eye had an IOP of 24 mm Hg
1 month postoperatively. This patient used brimonidine
for less than 1 week postoperatively. Another patient,
who had a postoperative IOP higher than 6 mm Hg in
both eyes, required treatment and had a quicker than usual
steroid taper. The remaining eyes with IOP increases higher
than 6 mm Hg did not require treatment. In addition, there
were 4 eyes treated with topical glaucoma medications pre-
operatively and 7 eyes treated with a topical glaucoma
medication for less than 1 week postoperatively that did
not develop a steroid response 1 month postoperatively.
According to the available medical data, no patients devel-
oped glaucomatous optic neuropathy.

Table 2. Preoperative and postoperative IOP measurements.

IOP Measurement (mm Hg)

Difluprednate (n Z 225 Eyes) Prednisolone Acetate (n Z 224 Eyes)

Examination Mean ± SD Range Median Mean ± SD Range Median P Value

Preop 15.4 G 2.9 8.0, 23.0 16.0 14.8 G 3.4 7.0, 29.0 14.0 .0626
1-mo postop 14.5 G 3.6 6.0, 35.0 14.0 14.3 G 3.4 6.0, 25.0 14.0 .6582
1-mo postop 1.0 G 4.0 13.0, 20.0 1.0 0.4 G 4.2 11.0, 12.0 1.0 .2803
change

IOP Z intraocular pressure.

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226 COMPARISON OF 2 STEROID EYEDROPS AFTER CATARACT SURGERY
Figure 1. Comparison of IOP measurements after use of diflupred-
nate or prednisolone acetate (IOP Z intraocular pressure).
DISCUSSION
The National Eye Institute estimates that the number of
people in the United States with cataract will double from
24.4 million in 2010 to approximately 50 million in
2050.A Data from the Centers for Medicaid and Medicare
Services indicate that the national cataract surgery rate
has risen from 13.4 per 1000 Medicare beneficiaries in
1980 to 61.8 per 1000 beneficiaries in 2004.5 The estimated
number of cataract surgeries in the U.S. billed to Medicare
in 2013 was 3.8 million. These increasing rates show the
importance of evaluating ways to standardize postoperative
care that is evidence-based and cost-effective.
Part of the difficulty in reviewing the literature on
corticosteroid-induced ocular hypertension is the
numerous ways this complication is defined. In 1965, Beck-
er6 used an absolute IOP of 20 mm Hg as the lower limit of a
clinically significant IOP response and an IOP of 31 mm Hg
as the cutoff value for stopping the use of betamethasone. In
1968, Armaly7 stratified a relative IOP steroid response
(increased IOP) into 3 groups: low (5 mm Hg or lower), in-
termediate (6 to 15 mm Hg), and high (16 mm Hg or high-
er). He used 6 mm Hg as the lower limit of a clinically
significant response. In 1984, Stewart et al.8 proposed that
an increase of 10 mm Hg or higher should be considered
clinically significant.
Although we used the corticosteroid-induced ocular hy-
pertension criteria set by Armaly,8 our conclusions would
have been similar if we used the definition from Stewart
et al.8 (1 eye [0.4%] in the difluprednate treatment group
and 1 eye [0.5%] in the prednisolone acetate treated group
showed an IOP increase higher than 10 mm Hg from base-
line to 1 month postoperatively).
There was a 2-fold difference between the prednisolone
acetate group and the difluprednate group (5.4% versus
2.7%, respectively) when examining the percentage of
eyes that had an increase in IOP higher than 6 mm Hg
from baseline to 1 month postoperatively. Although this
difference was not statistically significant, a larger study
would be necessary to fully evaluate this relative difference.
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To obtain IOP measurements, our study used a handheld
Tono-Pen applanation tonometer or a mounted Goldmann
applanation tonometer. In 2001, Iester et al.9 found that in
77% of patients who had IOP evaluated with both tonom-
eters, there was more than 3 mm Hg difference in measure-
ment. Although this introduces another variable into our
results, 92% of the IOP measurements in our study were
with the Goldmann applanation tonometer.
The dosing for both topical steroids in this study was at a
fixed schedule for the entire 30 days of treatment; therefore,
there was no tapering regiment. In the prednisolone acetate
cohort, the medication was administered 4 times a day and
in the difluprednate cohort, the medication was adminis-
tered 2 times a day.
In the initial clinical data submitted to the FDA for
approval of difluprednate, Korenfeld et al.10 found there
was a steroid response in 3% of patients regardless of
whether the medication was administered 2 times a day
or 4 times a day, whereas there was a steroid response in
1% of patients when a placebo was administered. Recently,
Jeng et al.4 found a statistically significant corticosteroid
IOP response in patients who took difluprednate versus
prednisolone acetate after vitreoretinal surgery. We believe
that the difference between our results and those of Jeng
et al. was that we only prescribed difluprednate twice a
day for 30 days, whereas Jeng et al. prescribed difluprednate
4 times a day for 30 days. The difference in dosage between
the 2 studies might explain why there was no statistical dif-
ference 1 month postoperatively in IOP increases higher
than 6 mm Hg between the 2 groups in our study. A study
powered for detecting the difference found we would
require a much larger sample size.
Patients who have an excessive amount of postoperative
inflammation or patients who might not be able to adhere
to 4 times a day dosing postoperatively might benefit
more from difluprednate use. In 1990, Eisen et al.11 re-
ported that less complicated dosing regimens result in bet-
ter adherence. For this reason, nepafenac 0.3% once daily
was used in the difluprednate group rather than nepafenac
0.1% 3 times daily in the prednisolone acetate group.
In addition, difluprednate was shown to have increased
bioavailability and dose uniformity resulting from the
formulation of difluprednate as an emulsion rather than a
suspension.12 In both circumstances, patients would benefit
with difluprednate, a medication that requires less frequent
dosing and has a better dose uniformity.
There is still considerable debate as to what is the most
effective postoperative management after cataract surgery.
Kessel et al.13 compared the use of nonsteroidal antiinflam-
matory drugs (NSAIDs) with the use of topical steroids in
patients who had uneventful cataract surgery. They
concluded that topical NSAIDs were more effective in
reducing inflammation and postoperative cystoid macular
edema, and there were no differences in adverse events or
visual outcomes.
The most notable limitation in this study is that it is a
retrospective chart review limited to a single center. Because
a consecutive series of patients was included in both steroid
 COMPARISON OF 2 STEROID EYEDROPS AFTER CATARACT SURGERY
groups, the inherent biases (selection bias in particular) are
mitigated. Also, our study was not powered to detect differ-
ences in IOP elevation of the low magnitude we observed,
although both groups showed low incidence rates with no
substantial absolute differences.
Another limitation is that it was not clear how long an
elevated IOP persists after discontinuation of topical ste-
roids in a patient with steroid response. The IOP could re-
turn to normal within 2 to 4 weeks after discontinuation of
corticosteroid therapy,14 although there is anecdotal data
that this response can be significantly quicker. In our study,
at the 1-month postoperative visit, 73.8% of the diflupred-
nate eyes and 63.8% of the prednisolone eyes were still
actively being treated with a topical steroid. This might be
an important variable to try to control, although it might
be difficult because the 1-month postoperative visit is usu-
ally scheduled based on both physician and patient avail-
ability. Until more data on how long a steroid response
lasts after discontinuation of topical steroid treatment are
available, the difference noted in this study might be usable.
In conclusion, patients who were treated with topical ste-
roids in this study had a low incidence of IOP elevation.
Even so, it is important to carefully monitor postoperative
patients using difluprednate or prednisolone acetate. Pa-
tients using either of these steroids to limit inflammation af-
ter cataract surgery can have a clinically significant steroid
response.
WHAT WAS KNOWN
 Anecdotal reports suggest significant steroid-induced ocular
hypertension might occur with the use of difluprednate or
prednisolone acetate. In particular, it has been hypothesized
that because of its increased potency, difluprednate use will
result in a greater incidence of corticosteroid response.
WHAT THIS PAPER ADDS
 There was no significant difference in corticosteroid-induced
ocular hypertension when comparing difluprednate with
prednisolone acetate at the dosing regimens prescribed in
this study.
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Disclosure: None of the authors has a financial or proprietary in-
terest in any material or methods mentioned.
First author:
Marius A. Tijunelis, MD, MBA
Department of Ophthalmology and Visual
Sciences, W.K. Kellogg Eye Center,
University of Michigan, Ann Arbor,
Michigan, USA
Volume 43 Issue 2 February 2017