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Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery

Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Edema

Intervention: Nepafenac 0.1% (Drug); Ketorolac 0.5% (Drug); Placebo (sterile saline drops) (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
Sherif El-Defrawy, MD PhD, Principal Investigator, Affiliation: Queen's University

Summary

Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).

Clinical Details

Official title: Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Change in macular volume (as quantified by OCT) at one month (compared to baseline)

Secondary outcome: COMTOL health-related quality-of-life

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ability to give informed consent

- Age 18 years and older

Exclusion Criteria:

- Any pre-existing retinal disease (e. g., diabetic retinopathy, vein occlusion,

exudative macular degeneration, etc.)

- Previous uveitis

- Previous intraocular surgery

- Allergy or hypersensitivity to NSAIDs

- Complicated cataract surgery

Locations and Contacts

Hotel Dieu Hospital, Kingston, Ontario K7L 3G2, Canada
Additional Information

Starting date: February 2010
Last updated: July 13, 2011

Page last updated: August 23, 2015

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