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NOT YET RECRUITING
NCT06498440
PHASE4

Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT

Sponsor: St. Joseph's Healthcare Hamilton

View on ClinicalTrials.gov

Summary

This clinical trial, led by Dr. Enitan A. Sogbesan at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton, aims to compare the efficacy and safety of non-steroidal anti-inflammatory drug (NSAID) ketorolac alone versus a combination of ketorolac and the corticosteroid fluorometholone, and a control group receiving no postoperative treatment. The trial will evaluate these treatment strategies following Selective Laser Trabeculoplasty (SLT) in patients with open-angle glaucoma. The primary objective is to determine the most effective postoperative management strategy to reduce inflammation, improve patient comfort, and control intraocular pressure (IOP). Participants will be randomly assigned to one of the three groups, with follow-up visits scheduled at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year post-SLT. The study's findings aim to guide clinicians in optimizing postoperative care for better patient outcomes.

Official title: Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-09-01

Completion Date

2025-07-01

Last Updated

2024-07-12

Healthy Volunteers

No

Interventions

DRUG

Ketorolac 0.5% Eye Drops

Participants in this arm will receive ketorolac 0.5% eye drops, administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the inflammatory process. This intervention aims to reduce postoperative inflammation and pain, promoting patient comfort and potentially improving outcomes following SLT.

DRUG

Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops

Participants in this arm will receive a combination of ketorolac 0.5% eye drops and fluorometholone 0.1% eye drops. Ketorolac will be administered twice daily and fluorometholone four times daily for one week following SLT. Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. The combination aims to maximize anti-inflammatory effects and enhance patient comfort, potentially leading to better postoperative outcomes compared to ketorolac alone or no treatment.

Locations (1)

St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute

Hamilton, Ontario, Canada