Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma

NCT07147647 | Recruiting FDA Device

• 1 other identifier: 25-SG27
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to evaluate how well Direct Selective Laser Trabeculoplasty (DSLT) lowers eye pressure in eyes of adult, non-Caucasian participants with primary open angle glaucoma. The main question it aims to answer is: What is the washed out eye pressure (eye pressure when not on any glaucoma medications) of participants 6 months after the Direct Selective Laser Trabeculoplasty (DSLT) procedure compared to the washed out eye pressure of participants prior to the DSLT procedure. Participants will: Undergo the DSLT procedure in one or both eyes and visit the clinic 1 month, 3 months, and 6 months after the procedure to have their vision and eye pressure measured.

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Direct Selective Laser Trabeculoplasty; DSLT; Primary Open Angle Glaucoma; POAG; Glaucoma

Outcome Measures

Primary Outcomes (1)

• IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.

  6 Months post-DSLT

Secondary Outcomes (6)

• Proportion of eyes with ≥ 20% washed out IOP reduction at 6 months post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP.

  6 months post-DSLT

• Proportion of medication free eyes at 6 months post-DSLT

  6 Months Post-DSLT

• The number of participants who require secondary interventions (additional IOP-lowering procedures) prior to the completion of the 6 month post-DSLT visit.

  6 Months Post-DSLT

• The number of participants who require secondary interventions (additional IOP-lowering medications) prior to the completion of the 6 month post-DSLT visit.

  6 Months Post-DSLT

• Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP

  1 month and 3 months post-DSLT

Study Arms (1)

Direct Selective Laser Trabeculoplasty

EXPERIMENTAL

Device: Direct Selective Laser Trabeculoplasty

Interventions

Direct Selective Laser Trabeculoplasty DEVICE

DSLT using the Belkin Vision Eagle Device

Direct Selective Laser Trabeculoplasty

Eligibility Criteria

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

You may qualify if:

• Adult patients of Black African descent scheduled to undergo DSLT treatment in one or both eyes.
• Diagnosis of mild to moderate primary open angle glaucoma (POAG).
• Mild to moderate POAG will be defined as Stage 2 or better of the Hodapp-Anderson-Parrish glaucoma staging system.
• Treatment naive or washed out IOP at time 0 ranging from ≥ 21 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).
• Secondary glaucoma:
• 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.
• Subjects who are pregnant, breast-feeding, or intend to become pregnant during the study period as determined by verbal inquiry.

Sponsors & Collaborators

• Select Eye Care: lead

Study Sites (1)

Select Eye Care

Elkridge, Maryland, 21075, United States

RECRUITING

Related Publications (8)

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• 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

• 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

• 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, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.

  PMID: 12049574 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

Related Links

• Change in Intraocular Pressure after Selective Laser Trabeculoplasty in North Indian Primary Open Angle Glaucoma Patients: A Prospective Analytical Study

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Scott E LaBorwit, MD

CONTACT

410-821-6400; scott.laborwit@vipeyes.com

Study Design

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

Model Details: Prospective, Single-Arm, Open-Label Clinical Trial

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 29, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)