Direct vs. Conventional SLT in Open-Angle Glaucoma: A RCT

September 29, 2025 updated by: Medical University of South Carolina

Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Glaucoma management is fundamentally aimed at reducing intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Selective Laser Trabeculoplasty (SLT) has been a cornerstone in the treatment of open-angle glaucoma due to its efficacy and safety profile. However, SLT's manual delivery method using a goniolens can introduce variability, patient discomfort, and operator dependency.

Direct Selective Laser Trabeculoplasty (DSLT) represents an innovative advancement, offering a non-contact, automated laser treatment via the Eagle system. This technology is designed to simplify the procedure, enhance patient comfort, and minimize operator-induced variability. Early evidence suggests that DSLT may provide similar or improved IOP reduction compared to SLT, with a potentially better safety profile.

This study seeks to rigorously evaluate whether DSLT is non-inferior to SLT in reducing IOP, thus providing critical data on the efficacy and safety of this novel approach. Demonstrating non-inferiority would support broader adoption of DSLT, potentially improving patient outcomes and expanding access to effective glaucoma treatment.

Study Type

Interventional

Enrollment (Estimated)

51

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
        • MUSC Health West Ophthalmology Clinic

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.
  • 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

Exclusion Criteria:

  • 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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1- DSLT (Direct Selective Laser Trabeculoplasty)
DSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation.
Device: DSLT treatment for Open-Angle Glaucoma
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.
Other: Arm 2- Selective Laser Trabeculoplasty (SLT)
SLT is a widely used and effective laser therapy to lower intraocular pressure that requires operator expertise and carries risks of mild inflammation, corneal damage and discomfort. This is a standard laser system that requires the use of a gonioscopy lens placed on the cornea to administer.
Device: SLT treatment for Open-Angle Glaucoma
To determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 6 months
Measuring the difference in the average IOP measurement reduction from the patient's baseline at 6 months between the DSLT and the SLT groups.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 12 months
The patients percentage of IOP reduction at 2 months, 6 months, and 12 months. Measuring the amount of patient's that have achieved >/= 20% IOP reduction at 6 months. Documentation of any change in the use of ocular hypotensive medications at 12 months. Documentation of the rate of repeat laser treatments or additional IOP lowering procedures.
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, MBA, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 7, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00142923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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