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

Official title

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Non-Caucasian Open Angle Glaucoma Patients

Overview

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.

Detailed description

The goal of this clinical trial is to evaluate intraocular pressure (IOP) reduction of Direct Selective Laser Trabeculoplasty (DSLT) treatment in eyes of non-Caucasian patients with primary open angle glaucoma by assessing the washed out IOP reduction of DSLT at 6 months (compared to washed out baseline IOP), measuring the success rate of achieving ≥ to 20% IOP reduction from washed out baseline, assessing the proportion of medication-free eyes at 6 months post-DSLT, the need for secondary intervention (additional medications or procedures) at 6 months post-DSLT, and by comparing the washed out IOP reduction at 6 months post-DSLT compared to the washed out baseline IOP according to trabecular meshwork pigmentation grade.

Interventions

• Device Direct Selective Laser Trabeculoplasty
  DSLT using the Belkin Vision Eagle Device

Primary outcome measures

• IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP. [Time frame: 6 Months post-DSLT]

Secondary outcome measures (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. [Time frame: 6 months post-DSLT]
• Proportion of medication free eyes at 6 months post-DSLT [Time frame: 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. [Time frame: 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. [Time frame: 6 Months Post-DSLT]
• Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP [Time frame: 1 month and 3 months post-DSLT]
• Mean 6 month washed out IOP reduction compared with washed out baseline IOP stratified by Trabecular Meshwork pigmentation grade. [Time frame: 6 Month Post-DSLT]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Select Eye Care — Elkridge

Publications

• Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059. PMID 19834563
• 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
• 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 PMID 16148589
• 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
• 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
• 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 PMID 36122660
• 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/bjop PMID 34433548
• 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

Identifiers

NCT: NCT07147647 · 25-SG27

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗