Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-C… (NCT06498440) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT
Canada126 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Intraocular Pressure (IOP) from Baseline