Direct vs Standard SLT for Glaucoma: A Noninferiority Trial
Purpose
This study compares two FDA-approved laser treatments for glaucoma: Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT). Both procedures aim to lower eye pressure and prevent vision loss. DSLT is a newer, non-contact technique that may improve comfort and efficiency. Participants will be randomly assigned to receive either DSLT or SLT and followed for 12 months to assess eye pressure, safety, and treatment outcomes.
Conditions
- Open-angle Glaucoma (OAG)
- Ocular Hypertension (OHT)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years - Diagnosis of OAG (including exfoliative or pigmentary) or OHT - Gonioscopically open angle (visible scleral spur 360°) - Ability to consent and comply with follow-up
Exclusion Criteria
- Angle-closure or secondary glaucomas - IOP >35 mmHg despite therapy - Corneal pathology interfering with laser or IOP measurement - Recent ocular surgery (<6 months) - Contraindications to study medications or procedures - Cognitive impairment preventing consent
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Direct Selective Laser Trabeculoplasty |
This arm is going to receive the Direct SLT treatment |
|
|
Active Comparator Traditional Selective Laser Trabeculoplasty |
This arm is going to receive the Traditional SLT treatment which will act as a control for the experimental arm. Note that both lasers are Standard of Care (SOC) and FDA approved |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Medical University of South Carolina