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

Cystoid Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025945
• Other study ID #: CME and nepafenac 0.3%
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: December 2018
• Source: Intuor Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Macular Edema

Intervention

Drug:
• Nepafenac 0.3%

• Saline Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intuor Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Clinical Findings of Cystoid Macular Edema	post-operative macular volume (mm)	6 weeks