Direct vs Standard SLT for Glaucoma: A Noninferiority Trial

May 4, 2026 updated by: Jella An, Medical University of South Carolina

A Randomized Controlled Trial Comparing Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • MUSC
        • Principal Investigator:
          • Jella An, MD, MBA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct Selective Laser Trabeculoplasty
This arm is going to receive the Direct SLT treatment
Device: Direct Selective laser Trabeculoplasty
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.
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
Device: Direct Selective laser Trabeculoplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Intraocular Pressure at 12 months from baseline
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Jella An, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00148724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a MUSC only clinical trial and the data from enrolled patients will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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