DSLT for Reducing Medication in Glaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Eye Institute of West Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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 population
Adults with ocular hypertension or POAG undergoing DSLT treatment in one or both eyes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Voyager DSLT
DeviceVoyager DSLT
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)
The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment.
Time frame
6 months post-DSLT treatmentSecondary outcomes
1
Change in intraocular pressure (IOP) from baseline
IOP will be measured using Goldmann applanation tonometry at each follow-up visit.
Time frame
6 months post-DSLT treatment2
Proportion of eyes needing medication stratified by number of IOP medications required
Time frame
6 months post-DSLT treatment3
Number and type of Secondary surgical interventions
Time frame
6 months post-DSLT treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Eye Institute of West Florida
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov