Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
1 other identifier
interventional
662
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedResults Posted
Study results publicly available
December 14, 2018
CompletedDecember 14, 2018
December 1, 2018
3.3 years
January 14, 2017
October 2, 2018
December 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative Clinical Findings of Cystoid Macular Edema
post-operative macular volume (mm)
6 weeks
Study Arms (2)
nepafenac 0.3%
EXPERIMENTALnepafenac 0.3% ophthalmic solution dosed once daily
Saline Solution
PLACEBO COMPARATORsterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Interventions
Eligibility Criteria
You may qualify if:
- Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
You may not qualify if:
- previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7.
PMID: 28219426DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sean McCafferty, MD
- Organization
- Arizona Eye Consultants
Study Officials
- PRINCIPAL INVESTIGATOR
Sean McCafferty, MD
Arizona Eye Consultants
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2017
First Posted
January 20, 2017
Study Start
October 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
December 14, 2018
Results First Posted
December 14, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share