Transcript JAMA Ophthalmology Journal Club Slides: Macular Edema After Cataract Surgery Diabetic Retinopathy Clinical Research Network.

JAMA Ophthalmology Journal Club Slides:
Macular Edema After Cataract Surgery
Diabetic Retinopathy Clinical Research Network. Macular edema after
cataract surgery in eyes without preoperative central-involved diabetic
macular edema. JAMA Ophthalmol. Published online April 18, 2013.
doi:10.1001/jamaophthalmol.2013.2313.
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Introduction
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There are limited data regarding visual acuity outcomes and development or
exacerbation of macular edema (ME) in individuals with diabetes mellitus undergoing
cataract surgery.
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Objective:
– To estimate the incidence of central-involved ME 16 weeks after cataract
surgery in eyes with preoperative evidence of diabetic retinopathy (DR) in the
absence of central-involved diabetic ME (DME) preoperatively.
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Methods
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Prospective multicenter observational study.
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Principal study participant criteria: aged ≥18 years; type 1 or 2 diabetes.
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Principal study eye criteria:
• Presence of cataract for which surgery is scheduled.
• Visual acuity of light perception or better.
• Surgery within 28 days of enrollment.
• Optical coherence tomographic (OCT) central subfield (CSF) thickness <250 µm
(<310 µm on spectral-domain [SD] OCT).
• Microaneurysms or at least mild nonproliferative DR.
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Data Analysis: Primary outcome was development of central-involved ME at 16 weeks with
≥1 of the following criteria:
• OCT CSF thickness ≥250 µm (≥310 from SD-OCT) plus ≥1-step increase in logOCT from
baseline.
• ≥2-Step increase in logOCT from baseline.
• Received nontopical postoperative ME treatment before 16 weeks with either of the OCT
criteria met at the time of treatment.
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Methods
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Visits
– Protocol visits included a baseline preoperative visit as well as 4-week and 16week postoperative visits.
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Limitations
– Treatment and prophylaxis for DME and cystoid ME prior to, during, and after
surgery were at the cataract surgeon’s or investigator’s discretion and hence
not standardized.
– Measurements of blood glucose, glycated hemoglobin, and blood pressure were
not obtained during follow-up; as such, cannot determine whether sudden
worsening of these features affected the outcomes.
– Topical nonsteroidal anti-inflammatory drugs or topical steroids were not
standardized; rather, these treatments were left to the discretion of the
investigator or cataract surgeon.
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Results
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At 16-week visit, no eyes without DME at baseline
(n = 17) developed central-involved ME (95% CI,
0%-20%).
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Of eyes where edema in the inner and outer macular
subfields on OCT was definite or possible, 10% (95%
CI, 5%-18%) of 97 eyes without central involvement and
12% (95% CI, 7%-19%) of 147 eyes where central
macular involvement was possible had progression to
definite central-involved ME.
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Of eyes that completed the 16-week visit, 8% received
postoperative treatment for ME.
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Potential baseline risk factors for the development of
central-involved ME or development or worsening of
non–central-involved ME include:
o Prior treatment for DME (P < .001).
o Poorer (worse) preoperative visual acuity (P = .06).
o More advanced (worse) level of DR (P = .06).
329 Eyes enrolled
(45 sites)
12 Eyes
canceled
surgery
24 Eyes
ineligible
293 Eyes eligible
14 Eyes
excluded
(1 death)
278 Eyes (95%) completed
4-week visit
279 Eyes (95%) completed
16-week visit
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Results
Visual Acuity at 16 Weeks
Did Not Develop
Central-Involved ME
(n = 246)
Developed
Central-Involved ME
(n = 30)
Baseline visual acuity
Mean ± SD letter score (Snellen equivalent)
67 ± 15 (20/50)
60 ± 15 (20/63)
Visual acuity at 16 wk
Mean ± SD letter score (Snellen equivalent)
80 ± 11 (20/25)
69 ± 12 (20/40)
13 ± 14
9 ± 14
20/40 or better
89%
67%
≥10-Letter gain (approximately ≥2 lines)
55%
37%
≥10-Letter loss (approximately ≥2 lines)
3%
10%
Visual acuity change from baseline
Mean ± SD letters
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Results
Baseline Factors’ Association With Development of
Central-Involved ME at 16 Weeks
Baseline Factor
Total, No.
Proportion With
Central-Involved
ME
Visual acuity at baseline, letter score (Snellen
equivalent)
.06
≥69 (≥20/40)
144
7%
68-54 (20/50-20/80)
91
13%
53-39 (20/100-20/160)
23
22%
≤38 (≤20/200)
18
17%
Any history of DME treatment
<.001
Yes
123
20%
No
153
4%
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P Value
Results
Baseline Factors’ Association With Development of
Central-Involved ME at 16 Weeks (continued)
Baseline Factor
Total,
No.
Proportion With
Central-Involved ME
History of panretinal photocoagulation
prior to study
.50
Yes
68
13%
No
208
10%
DR severity
.06
Microaneurysms only
54
4%
Mild/moderate nonproliferative DR
128
9%
Severe nonproliferative DR
Proliferative DR and/or prior scatter laser
photocoagulation
14
14%
80
18%
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P Value
Comment
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In eyes without central-involved DME within 1 month prior to undergoing cataract
extraction, no eyes without any DME at baseline developed central-involved ME,
although the size of this subgroup was limited (n = 17 at 16 weeks).
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The incidence rates in the subgroups with preoperative DME not involving the CSF and
the subgroup with DME with possible center involvement before cataract surgery were
comparable at about 10%.
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Eyes with a history of DME treatment prior to study entry had a higher rate of centralinvolved ME (20%) than eyes with no history of DME treatment (4%) (P < .001) 16
weeks following cataract surgery.
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Overall, 86% of eyes had visual acuity of 20/40 or better. Visual acuity of this level is
generally attained in a larger proportion of eyes undergoing cataract surgery among
persons without diabetes.
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Strengths of the study include the large sample size and the multicenter nature, which
provide more precise estimates for the progression of ME after cataract surgery.
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Lack of standardization of DME treatment is a limiting factor of the study.
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Comment
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This study shows that eyes with a history of DME treatment or DME immediately
prior to cataract surgery are at higher risk for developing central-involved ME 16
weeks after the cataract extraction than those with no history of DME treatment or
DME within 1 month of surgery.
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The effect of preoperative DME treatment on postoperative ME could not be
evaluated in this study.
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Clinicians should continue to maintain vigilance in diabetic patients after cataract
extraction even when central ME is not present immediately prior to cataract
surgery, especially in eyes with prior DME treatment or non–central-involved DME
that may be at a particularly high risk for development of central-involved ME after
cataract surgery.
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These data may help researchers planning future clinical trials that attempt to
minimize this clinically important event. It may also help physicians to explain the risk
of DME progression after cataract surgery to their patients, tailored according to
location of DME and history of DME treatment in a particular eye.
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Contact Information
•
If you have questions, please contact the corresponding author:
– Talat Almukhtar, MBChB, Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350,
Tampa, FL 33647 ([email protected]).
Funding/Support
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This work was supported through cooperative agreements EY14231 and EY018817 from the
National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health, US Department of Health and Human Services.
Conflict of Interest Disclosures
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A complete list of all DRCR.net investigator financial disclosures is available at http:// www.drcr.net.
The National Institutes of Health participated in oversight of the conduct of the study and review of
the manuscript but not directly in the design or conduct of the study; in the collection, analysis, and
interpretation of the data; or in the preparation or approval of the manuscript.
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