N/A
N=662
Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Cystoid Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT03025945 ↗Enrolled (actual)
662
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Post-operative Clinical Findings of Cystoid Macular Edema — 8.85; 8.95 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nepafenac 0.3% (Drug); Saline Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intuor Technologies, Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Clinical Findings of Cystoid Macular Edema |
8.85; 8.95 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03025945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.