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

July 5, 2024 updated by: Enitan Sogbesan, St. Joseph's Healthcare Hamilton

Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Enitan A Sogbesan, MD
  • Phone Number: 38311 (905) 573-7777
  • Email: bainss@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8G 4X3
        • St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ketorolac 0.5% Eye Drops
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 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.
Other Names:
  • Acular
  • Acuvail
  • Acular LS
Experimental: 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.
Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
Participants 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.
Other Names:
  • Acular
  • Acuvail
  • FML
  • Fluor-Op
No Intervention: No Treatment Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 1 year post-SLT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline to 1 year post-SLT
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.
Baseline to 1 year post-SLT
Anterior Chamber Inflammation
Time Frame: Baseline to 1 year post-SLT
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.
Baseline to 1 year post-SLT
Patient-Reported Discomfort
Time Frame: Baseline to 1 year post-SLT
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.
Baseline to 1 year post-SLT
Incidence of Postoperative Complications
Time Frame: Baseline to 1 year post-SLT
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.
Baseline to 1 year post-SLT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Enitan A Sogbesan, MD, St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17189 (UKCRN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The decision to share individual participant data (IPD) with other researchers is currently under consideration. The final decision will be made in alignment with institutional policies and ethical guidelines to ensure the protection of participant confidentiality and the integrity of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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