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

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.

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Key information

Conditions

CYSTOID MACULAR EDEMA Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nepafenac 0.3%

Drug

Saline Solution

Drug

Primary outcomes

Post-operative Clinical Findings of Cystoid Macular Edema

Time frame: 6 weeks

post-operative macular volume (mm)

Sponsors and collaborators

Lead sponsor

Intuor Technologies, Inc.

Industry

Registry information

Official study title

Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jan 20, 2017
Registry last updated: Dec 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed