The Eye Institute of West Florida
Largo, Florida, 33770, United States
Location status: Recruiting
NCT Number: NCT07390890
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.
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Observational
Largo, Florida, 33770, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Voyager DSLT
Time frame: 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.
Time frame: 6 months post-DSLT treatment
IOP will be measured using Goldmann applanation tonometry at each follow-up visit.
Time frame: 6 months post-DSLT treatment
Time frame: 6 months post-DSLT treatment
Contact information is provided by the study sponsor or research team.
The Eye Institute of West Florida
Other
Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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