The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.
Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.
Wilmer Eye Institute
Baltimore, Maryland, United States
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Time frame: Baseline and Week 12
Mean Change in Central Subfield Thickness at Week 12 From Baseline
Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Time frame: Baseline and Week 12
Mean Change in Intraocular Pressure at Week 12 From Baseline
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Time frame: Baseline and Week 12
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Time frame: Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Time frame: Week 12 and Week 48
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Time frame: Week 12 and Week 48
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