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

St. Joseph's Healthcare Hamilton

Status and phase: Not yet enrolling; Phase 4

Conditions: Open Angle Glaucoma; Postoperative Inflammation; Ocular Hypertension

Treatments: Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops; Drug: Ketorolac 0.5% Eye Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT06498440

17189 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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126 participants in 3 patient groups

Ketorolac Alone

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac 0.5% Eye Drops

Ketorolac with Fluorometholone

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops

No Treatment Control

No Intervention group

Description:

Participants in this arm will not receive any postoperative treatment following Selective Laser Trabeculoplasty (SLT). This control group is included to provide a baseline for comparison against the treatment groups receiving ketorolac alone or a combination of ketorolac and fluorometholone. The purpose is to assess the natural course of postoperative inflammation and patient comfort without intervention.