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

NCT06925477 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: Pro00142923
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

Open Angle Glaucoma; SLT; Trabeculoplasty; DSLT

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  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 Outcomes (1)

• Secondary Outcome

  12 months

Study Arms (2)

Arm 1- DSLT (Direct Selective Laser Trabeculoplasty)

OTHER

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

Arm 2- Selective Laser Trabeculoplasty (SLT)

OTHER

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

Interventions

DSLT treatment for Open-Angle Glaucoma DEVICE

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.

Arm 1- DSLT (Direct Selective Laser Trabeculoplasty)

SLT treatment for Open-Angle Glaucoma DEVICE

To determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma.

Arm 2- Selective Laser Trabeculoplasty (SLT)

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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC Health West Ophthalmology Clinic

Charleston, South Carolina, 29407, United States

Location

Related Publications (3)

• Konstantakopoulou E, Gazzard G, Garway-Heath D, Adeleke M, Ambler G, Vickerstaff V, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Selective Laser Trabeculoplasty After Medical Treatment for Glaucoma or Ocular Hypertension. JAMA Ophthalmol. 2025 Apr 1;143(4):295-302. doi: 10.1001/jamaophthalmol.2024.6492.

  PMID: 39976961 RESULT

• Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167/tvst.10.3.5.

  PMID: 34003939 RESULT

• Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.

  PMID: 32106630 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Jella An, MD, MBA

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)