Direct vs Standard SLT for Glaucoma: A Noninferiority Trial

NCT07408154 | Recruiting DMC FDA Device

• 1 other identifier: Pro00148724
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Keywords

Glaucoma; Open-Angle Glaucoma; Ocular Hypertension; Laser Trabeculoplasty; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure at 12 months from baseline

  12 months

Study Arms (2)

Direct Selective Laser Trabeculoplasty

EXPERIMENTAL

This arm is going to receive the Direct SLT treatment

Device: Direct Selective laser Trabeculoplasty

Traditional Selective Laser Trabeculoplasty

ACTIVE COMPARATOR

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

Device: Direct Selective laser Trabeculoplasty

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.

Direct Selective Laser Trabeculoplasty; Traditional Selective Laser Trabeculoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC

Charleston, South Carolina, 29407, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Jella An, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor-Faculty

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)