Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center For Excellence In Eye Care
• Treatments: Bromfenac; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• · Male or female > 18 years of age scheduled to undergo cataract surgery

• Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)

• Expected visual outcome of 20/25 or better.

• Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

• · Known contraindication to any study medication or any of their components

• Uncontrolled systemic disease

• Required use of ocular medications other than the study medications during the study

• Abnormal pre-operative OCTs

• Diabetic patients with a history of macular edema or diabetic retinopathy

• AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

• Only one eye of each patient can be enrolled