Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma. The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT. Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
Interventions
DEVICEVoyager DSLT
Voyager DSLT
Sponsors
The Eye Institute of West Florida
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adult patients scheduled to undergo DSLT treatment in one or both eyes. * Diagnosis of ocular hypertension or primary open angle glaucoma (POAG). * Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.
Exclusion criteria
* Previous glaucoma surgeries/interventions: * Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt). * Patients who have undergone cataract surgery within the prior 2 years. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP) | 6 months post-DSLT treatment | The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in intraocular pressure (IOP) from baseline | 6 months post-DSLT treatment | IOP will be measured using Goldmann applanation tonometry at each follow-up visit. |
| Proportion of eyes needing medication stratified by number of IOP medications required | 6 months post-DSLT treatment | — |
| Number and type of Secondary surgical interventions | 6 months post-DSLT treatment | — |
Countries
United States
Contacts
CONTACTRenee Bondurant
PRINCIPAL_INVESTIGATORNeel Desai, MD
The Eye Institute of West Florida
Outcome results
None listed