The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
263
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
Time frame: 3 Months
Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
Time frame: From Day 7 to Day 90 (or Early Exit)
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