ClinicalTrials.gg
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

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 51 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years.
  • Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT.
  • Gonioscopically visible scleral spur for 360 degrees.
  • Ability to provide .
  • 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
  • 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 , MLT and SLT.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

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.

06

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

07

Study locations

1 site
  • MUSC Health West Ophthalmology Clinic
    Charleston, South Carolina 29407, United States
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Oct 2027, 26 months after the start.

Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 26 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2025
First posted
Apr 13, 2025
StartActual
Aug 7, 2025
Primary completionEst.
Oct 31, 2027
CompletionEst.
Nov 30, 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06925477
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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