Direct vs Standard SLT for Glaucoma: A Noninferiority Trial

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07408154
Status
Recruiting
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Conditions

  • Ocular Hypertension (OHT)
  • Open-angle Glaucoma (OAG)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Direct Selective laser Trabeculoplasty — DEVICE
    The Direct Selective Laser Trabeculoplasty is a non-contact laser designed to manage IOP in patients with glaucoma. The traditional SLT required a gonioscopy lens to be placed over the patient's eyes to direct the laser towards the trabecular meshwork.

Study Details

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.

Key Dates

Start date
Apr 27, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in Intraocular Pressure at 12 months from baseline [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
MUSCCharlestonSouth Carolina29407
Jella An, MD, MBA
[email protected]
843-792-1443
Jella An, MD, MBA (PRINCIPAL_INVESTIGATOR)

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