Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ketorolac 0.5% Eye Drops
- Conditions
- Open Angle Glaucoma
- Sponsor
- St. Joseph's Healthcare Hamilton
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Change in Intraocular Pressure (IOP) from Baseline
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Selective Laser Trabeculoplasty (SLT) is a widely used procedure introduced by Latina and Park in 1995 for the management of various forms of glaucoma, including open-angle glaucoma (OAG), pigmentary glaucoma, pseudoexfoliation glaucoma, and ocular hypertension. SLT helps prevent irreversible blindness by effectively managing these conditions. However, postoperative management strategies vary among practitioners, with some prescribing NSAIDs, a combination of NSAIDs and steroids, or no treatment at all. There is no consensus on the most effective and safest approach. This phase 4 single-centre randomized controlled trial seeks to address this knowledge gap by comparing the postoperative effects of ketorolac alone, a combination of ketorolac and fluorometholone, and a no treatment control group on inflammation and patient comfort following SLT. The hypothesis is that treatment with ketorolac alone or in combination with fluorometholone will show superior results in reducing inflammation and improving patient comfort compared to no treatment. The study will enroll patients undergoing SLT at the Hamilton Regional Eye Clinic. Participants will be randomized into either one of two treatment groups or one control group (no treatment) and monitored for changes in IOP, visual acuity, patient comfort, and the occurrence of any complications over a one-year period. Data collected from these assessments will be analyzed to determine the comparative efficacy and safety of the three strategies. Inclusion criteria include adults diagnosed with open-angle glaucoma, IOP greater than 16 mmHg, and visual acuity of 20/200 or better. Exclusion criteria include recent ocular surgeries, allergies to ketorolac or fluorometholone, and pregnancy. The primary outcome measure is the change in IOP from baseline, while secondary outcomes include visual acuity, anterior chamber inflammation, and patient-reported discomfort. The trial follows CONSORT guidelines to maintain transparency and reproducibility. Ethical approval will be obtained from the Hamilton Integrated Research Ethics Board (HiREB), ensuring compliance with ethical and legal requirements. The results of this study will inform postoperative care decisions following SLT, potentially leading to improved patient outcomes and satisfaction. This trial also aims to contribute to a more standardized postoperative management protocol for SLT, enhancing clinical practice and patient care in glaucoma treatment.
Investigators
Enitan Sogbesan
Dr. Enitan Sogbesan, Principal Investigator
St. Joseph's Healthcare Hamilton
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18 years and older.
- •Diagnosed with open-angle glaucoma.
- •Intraocular pressure (IOP) greater than 16 mmHg on at least two consecutive occasions separated by one month.
- •Visual acuity of 20/200 or better in at least one eye.
- •Provided informed consent.
Exclusion Criteria
- •Patients with any other ocular disorders or surgeries within the last six months.
- •Allergy or intolerance to ketorolac or fluorometholone.
- •Previous use of systemic ketorolac or fluorometholone in the past month.
- •Pregnancy or breastfeeding.
- •Patients who are unable to speak/understand English.
- •Any condition that in the investigator's opinion would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified assessments.
Arms & Interventions
Ketorolac Alone
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 helps reduce inflammation and alleviate pain. The purpose of this intervention is to assess the efficacy and safety of ketorolac alone in managing postoperative inflammation and patient comfort compared to other treatment strategies.
Intervention: Ketorolac 0.5% Eye Drops
Ketorolac with Fluorometholone
Participants in this arm will receive a combination of ketorolac 0.5% eye drops administered twice daily and fluorometholone 0.1% eye drops administered four times daily for one week following Selective Laser Trabeculoplasty (SLT). Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. This arm aims to evaluate the combined efficacy and safety of ketorolac and fluorometholone in postoperative care.
Intervention: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
Outcomes
Primary Outcomes
Change in Intraocular Pressure (IOP) from Baseline
Time Frame: Baseline to 1 year post-SLT
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.
Secondary Outcomes
- Visual Acuity(Baseline to 1 year post-SLT)
- Patient-Reported Discomfort(Baseline to 1 year post-SLT)
- Incidence of Postoperative Complications(Baseline to 1 year post-SLT)
- Anterior Chamber Inflammation(Baseline to 1 year post-SLT)