Primary Open Angle Glaucoma (POAG)
Conditions
Keywords
Direct Selective Laser Trabeculoplasty, DSLT, Primary Open Angle Glaucoma, POAG, Glaucoma
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.
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
DSLT using the Belkin Vision Eagle Device
Sponsors
Select Eye Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single-Arm, Open-Label Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP. | 6 Months post-DSLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of medication free eyes at 6 months post-DSLT | 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. | 6 Months Post-DSLT | — |
| 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 | — |
| Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP | 1 month and 3 months post-DSLT | Measured in mmHg by Goldmann Applanation Tonometry |
| Mean 6 month washed out IOP reduction compared with washed out baseline IOP stratified by Trabecular Meshwork pigmentation grade. | 6 Month Post-DSLT | Trabecular meshwork pigment will be graded on a scale of 0-4 where 0 is no pigment and 4 is heavy pigmentation |
| 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 | — |
Countries
United States
Contacts
Primary ContactScott E LaBorwit, MD
Outcome results
None listed