Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498440
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Efficacy of NSAID vs Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty Phase 4 Single-Center RCT
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty a Phase 4 Single-centre Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CES-NSLT
Brief Summary:
This clinical trial led by Dr Enitan A Sogbesan at the Hamilton Regional Eye Clinic St Josephs 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 studys 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 20200 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
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 20200 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None