Status:
ENROLLING_BY_INVITATION
Direct vs. Conventional SLT in Open-Angle Glaucoma: A RCT
Lead Sponsor:
Medical University of South Carolina
Conditions:
GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires ...
Detailed Description
Glaucoma management is fundamentally aimed at reducing intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Selective Laser Trabeculoplasty (SLT) has been a cornerstone in the...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT.
- Gonioscopically visible scleral spur for 360 degrees.
- Ability to provide informed consent.
- In good health, without prior laser trabeculoplasty, with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both.
- Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
- High-risk ocular hypertension (OHT): IOP \> 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of \>0.2 between eyes) \[enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment\]
- Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation \>-6.0 dB with no points in the central 5° \<15 dB
- Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to \>-12 dB and no more than 1 central 5° point \<15 dB
Exclusion
- Advanced POAG in either eye
- Glaucoma other than OAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
- Mean IOP \> 35 mmHg at either the screening or baseline visit in either eye
- Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
- Contraindications to SLT, brimonidine, apraclonidine, or any other study intervention
- Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
- Any intraocular surgical procedure within the past 6 months in either eye
- Inability to attend all scheduled study visits
- Pregnancy or plan to become pregnant in the next 1 year
- Any prior laser trabeculoplasty, including ALT, MLT and SLT.
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06925477
Start Date
August 7 2025
End Date
August 31 2026
Last Update
October 2 2025
Active Locations (1)
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1
MUSC Health West Ophthalmology Clinic
Charleston, South Carolina, United States, 29407