Clinical trial NCT06498440: Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT
Official title: Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Open Angle Glaucoma
Ocular Hypertension
Postoperative Inflammation
Keywords: Selective Laser Trabeculoplasty (SLT)
Non-steroidal anti-inflammatory drugs (NSAIDs)
Ketorolac
Fluorometholone
Postoperative care
Intraocular pressure (IOP)
Visual acuity
Glaucoma treatment
Ophthalmology
Randomized controlled trial (RCT)
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study is a Phase 4 single-centre randomized controlled trial (RCT) at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton. It aims to compare postoperative treatments following Selective Laser Trabeculoplasty (SLT) in open-angle glaucoma patients. Participants are randomly assigned to one of three groups: ketorolac alone, ketorolac with fluorometholone, or no treatment (control). The primary outcome is the change in intraocular pressure (IOP) from baseline to one year post-SLT, with secondary outcomes including visual acuity, inflammation, and patient-reported discomfort. Follow-up assessments occur at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year. The study follows CONSORT guidelines and has ethical approval from the Hamilton Integrated Research Ethics Board (HiREB). The goal is to provide reliable data on effective postoperative management strategies, enhancing clinical practice in glaucoma treatment.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) from Baseline
timeFrame: Baseline to 1 year post-SLT
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline to 1 year post-SLT
measure: Anterior Chamber Inflammation
timeFrame: Baseline to 1 year post-SLT
measure: Patient-Reported Discomfort
timeFrame: Baseline to 1 year post-SLT
measure: Incidence of Postoperative Complications
timeFrame: Baseline to 1 year post-SLT
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Enitan A Sogbesan, MD
role: PRINCIPAL_INVESTIGATOR
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