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

Center For Excellence In Eye Care95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cystoid Macular Edema,Retinal Thickening

Interventions

2. Xibrom (Bromfenac)DRUG

Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.

1. Pred ForteDRUG

Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks. Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Center for Excellence in Eye Care

Miami, Florida, United States

Outcomes

Primary Outcomes

Cystoid Macular Edema

Time frame: 11 months

Secondary Outcomes

Retinal Thickening

Time frame: 11 months

Data from ClinicalTrials.gov

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