About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0).
Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
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.
Trial design
Single group
Treatments tested in this trial
Direct Selective Laser Trabeculoplasty
DeviceDSLT using the Belkin Vision Eagle Device
Treatment groups
Trial outcomes
Primary outcomes
IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.
Secondary outcomes
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.
Proportion of medication free eyes at 6 months post-DSLT
Eyes not using any glaucoma medications
The number of participants who require secondary interventions (additional IOP-lowering procedures) prior to the completion of the 6 month post-DSLT visit.
The number of participants who require secondary interventions (additional IOP-lowering medications) prior to the completion of the 6 month post-DSLT visit.
Sponsors and contacts
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