Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT

NCT07589270 | Not Yet Recruiting FDA Device

• 1 other identifier: NMR-15213
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients. Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT. The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment. The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.

Conditions

Ocular Hypertension Glaucoma; POAG

Outcome Measures

Primary Outcomes (1)

• Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated with Selective Laser Trabeculoplasty (SLT)

  IOP measured using Goldmann applanation tonometry. Washed-out IOP assessed at baseline prior to DSLT and at 6 months post-treatment following protocol-defined medication washout.

  baseline through 6 months post DSLT treatment

Study Arms (1)

DSLT Treatment

EXPERIMENTAL

Participants undergo direct selective laser trabeculoplasty (DSLT) in one eye using a fixed-energy protocol (120 shots, 400 µm spot size, 1.8 mJ, no titration). Intraocular pressure (IOP) is assessed at baseline (following medication washout) and during follow-up visits at 1 month, 3 months, and 6 months. A medication washout is required prior to baseline and the 6-month assessment. IOP-lowering medications may be introduced during follow-up based on investigator-defined thresholds.

Device: DSLT

Interventions

DSLT DEVICE

Eligible participants will undergo the DSLT procedure: 120 shots, 400 µm spot size, 1.8mJ fixed energy (no titration) delivered at the limbus over 2.4 seconds

DSLT Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye.
• Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG).
• Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 through 32 mm Hg.

You may not qualify if:

• Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0)
• Previous glaucoma surgeries/interventions:
• Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
• Recent SLT failures (within 6 months of initial treatment).
• Patients who have undergone cataract surgery within the prior 2 years.
• Secondary glaucoma:
• o Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.
• Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.

Sponsors & Collaborators

• The New York Eye Surgery Center: lead

Study Sites (1)

New York Eye Surgery Center

The Bronx, New York, 10469, United States

Location

Related Publications (9)

• Hughes BA, Bacharach J, Craven ER, Kaback MB, Mallick S, Landry TA, Bergamini MV. A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. J Glaucoma. 2005 Oct;14(5):392-9. doi: 10.1097/01.ijg.0000176935.08392.14.

  PMID: 16148589 BACKGROUND

• Remo S, Roberto M. Staging Glaucoma Patient: Why and How?. Open Ophthalmol J, 2009; 3: http://dx.doi.org/10.2174/1874364100903010059

  BACKGROUND

• Supriya M Buraniya et al., Change in IOP after Selective Laser Trabeculoplasty in North Indian Primary Open Angle Glaucoam Patients: A Prospective Analytical Study. Journal of Clinical and Diagnostic Research. 2024 Nov, Vol-18(11): NC01-NC06

  BACKGROUND

• Racette L, Wilson MR, Zangwill LM, Weinreb RN, Sample PA. Primary open-angle glaucoma in blacks: a review. Surv Ophthalmol. 2003 May-Jun;48(3):295-313. doi: 10.1016/s0039-6257(03)00028-6.

  PMID: 12745004 BACKGROUND

• Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JK, Miller JP, Parrish RK, Wilson MR; Ocular Hypertension Treatment Study Group. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.

  PMID: 20212196 BACKGROUND

• Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016/j.ajo.2005.07.044.

  PMID: 16386972 BACKGROUND

• Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016/j.ophtha.2022.09.009. Epub 2022 Sep 17.

  PMID: 36122660 BACKGROUND

• Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.

  PMID: 34433548 BACKGROUND

• 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 BACKGROUND

Study Officials

• Nathan Radcliffe, M.D.

  New York Eye Surgery Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krystina Tavarez Feliciano, B.A

CONTACT

718-519-1000; krystinafeliciano23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: VOYAGER DSLT

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: May 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available beginning 6 months following publication of the primary results and ending 5 years after publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Requests should be directed to the study sponsor or principal investigator. A data use agreement may be required. Supporting documents, including the study protocol and statistical analysis plan, will also be made available.

Locations

US (1)