What this study is
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 a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. The study will evaluate whether DSLT is as effective as SLT in reducing intraocular pressure (IOP). Participants will be randomly assigned to receive either treatment and will be monitored over 12 months to assess changes in IOP, medication use, and safety outcomes. The goal is to determine if the simpler DSLT procedure can provide similar results to SLT, potentially improving patient comfort and access to glaucoma care.
What's being tested
- DSLT treatment for Open-Angle Glaucoma
Intervention · DEVICE
This intervention aims to determine the efficacy and safety of Direct Selective Laser Trabeculoplasty (DSLT) in reducing intraocular pressure in patients with open-angle glaucoma.
- SLT treatment for Open-Angle Glaucoma
Intervention · DEVICE
To determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma.
Study details
- Official title
- Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma
- Sponsor
- Medical University of South Carolina
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Enrolling
- 51 people
- Starts
- 2025-08-07
- Est. completion
- 2027-11-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMUSC Health West Ophthalmology Clinic
Charleston, South Carolina, United States
Study team
Sponsor
Medical University of South Carolina
Study ID Pro00142923
Principal investigator
Jella An, MD, MBA
Medical University of South Carolina
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.