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Enrolling by invitationNCT06925477Updated Sep 14, 2026

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

An interventional study of DSLT treatment for Open-Angle Glaucoma and SLT treatment for Open-Angle Glaucoma in GLAUCOMA 1, OPEN ANGLE, D (Disorder), sponsored by Medical University of South Carolina. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • GLAUCOMA 1, OPEN ANGLE, D (Disorder)

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Keywords

  • Open Angle Glaucoma
  • SLT
  • Trabeculoplasty
  • DSLT
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
51 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceDSLT 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.

  • DeviceSLT treatment for Open-Angle Glaucoma

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

05

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Secondary Outcome

    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.

    Time frame: 12 months

06

Study locations

1 site
  • MUSC Health West Ophthalmology Clinic
    Charleston, South Carolina 29407, United States
07

References and documents

Publications

  • 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. PubMed 39976961 ↗
  • 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. PubMed 34003939 ↗
  • 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. PubMed 32106630 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06925477
Lead sponsor
Medical University of South Carolina
Responsible party
Jella An (Clinical Professor-Faculty, Medical University of South Carolina) — Principal investigator
First posted
Apr 13, 2025
Start date
Aug 7, 2025
Primary completion
Oct 31, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Jella An, MD, MBA
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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