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Recruiting NCT07390890

DSLT for Reducing Medication in Glaucoma

Observational Primary Open Angle Glaucoma Ocular Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voyager DSLT.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma, Ocular Hypertension. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma

Overview

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

  • Device Voyager DSLT
    Voyager DSLT

Primary outcome measures

  • Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP) [Time frame: 6 months post-DSLT treatment]
Secondary outcome measures (3)
  • Change in intraocular pressure (IOP) from baseline [Time frame: 6 months post-DSLT treatment]
  • Proportion of eyes needing medication stratified by number of IOP medications required [Time frame: 6 months post-DSLT treatment]
  • Number and type of Secondary surgical interventions [Time frame: 6 months post-DSLT treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Eye Institute of West Florida — Largo

Identifiers

NCT: NCT07390890 · ND-25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗