Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT
NCT Number: NCT06498440
Acronym: CES-NSLT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Open Angle Glaucoma|Ocular Hypertension|Postoperative Inflammation
Interventions: DRUG: Ketorolac 0.5% Eye Drops|DRUG: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
Sponsor: St. Joseph's Healthcare Hamilton
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-07-01
Locations: St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute, Hamilton, Ontario, L8G 4X3, Canada

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.

Primary Outcome Measures: Change in Intraocular Pressure (IOP) from Baseline, The primary outcome measure is the mean change in intraocular pressure (IOP) from baseline to 1 year post-Selective Laser Trabeculoplasty (SLT). IOP will be measured using Goldmann applanation tonometry (GAT) at each follow-up visit. The baseline IOP is determined as the average of measurements taken on the day of SLT booking and on the day of the SLT procedure. The primary objective is to compare the effectiveness of ketorolac alone, ketorolac with fluorometholone, and no treatment in reducing IOP following SLT., Baseline to 1 year post-SLT
Secondary Outcome Measures: Visual Acuity, Visual acuity will be measured using a Snellen chart and reported in logMAR units at each follow-up visit. The study will compare changes in visual acuity among the three treatment groups to determine the impact of each postoperative strategy on visual function., Baseline to 1 year post-SLT|Anterior Chamber Inflammation, Anterior chamber inflammation will be assessed using the Standardization of Uveitis Nomenclature (SUN) Working Group grading system. The presence and severity of cells and flare in the anterior chamber will be evaluated at each follow-up visit to compare the anti-inflammatory effects of the treatment strategies., Baseline to 1 year post-SLT|Patient-Reported Discomfort, Patient discomfort will be recorded at each follow-up visit. Participants will rate their discomfort on a scale, allowing for comparison of patient comfort levels across the three treatment groups., Baseline to 1 year post-SLT|Incidence of Postoperative Complications, The incidence of postoperative complications, such as ocular discomfort, conjunctival hyperemia, and corneal abrasions, will be recorded at each follow-up visit. This measure will help determine the safety profile of ketorolac alone, ketorolac with fluorometholone, and no treatment following SLT., Baseline to 1 year post-SLT