Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ketorolac 0.5% Eye Drops
DrugParticipants 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.
Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
DrugParticipants 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.
Treatment groups
126 Participants
are divided into 3 treatment groupsGroup A: Ketorolac AloneExperimental treatment 1 intervention
Group B: Ketorolac with FluorometholoneExperimental treatment 1 intervention
Group C: No Treatment ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 1 year post-SLTSecondary outcomes
1
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.
Time frame
Baseline to 1 year post-SLT2
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.
Time frame
Baseline to 1 year post-SLT3
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.
Time frame
Baseline to 1 year post-SLT4
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.
Time frame
Baseline to 1 year post-SLTSponsors and contacts
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Source ClinicalTrials.gov
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