Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Age more than or equal to 18 years
Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.

Exclusion Criteria

Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
Pre-existing diagnosis of glaucoma in the study eye
Inability to comply with study or follow up procedures
Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).

Arm && Interventions

Group	Intervention	Description
PredA q1h WA + Kelac qid	PredA + Kelac	Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
PredA qid + Kelac qid	PredA + Kelac	Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)

Primary Outcome Measures

Name	Time	Method
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline	Baseline and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure at Week 12 From Baseline	Baseline and Week 12	Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48	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.
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48	Week 12 and Week 48	Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Mean Change in Intraocular Pressure Between Week 12 and Week 24	Week 12 and Week 48	Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Mean Change in Central Subfield Thickness at Week 12 From Baseline	Baseline and Week 12	Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline