Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Intuor Technologies, Inc.662 enrolled

Overview

Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

662

Conditions

Cystoid Macular Edema

Interventions

Nepafenac 0.3%DRUG

Saline SolutionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens. Exclusion Criteria: * previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs

Outcomes

Primary Outcomes

Post-operative Clinical Findings of Cystoid Macular Edema

post-operative macular volume (mm)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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