Recruiting

DSLT

Sponsor:

The Eye Institute of West Florida

Code:

NCT07390890

Conditions

Primary Open Angle Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Voyager DSLT

Study Details

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.

Conditions

Primary Open Angle Glaucoma

Ocular Hypertension

Study ID

NCT07390890

Start date

Feb 10, 2026

Status verified date

Apr, 2026

Completion date

Jan 26, 2027

Anticipated

Primary completion date

Jan 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Voyager DSLT

Voyager DSLT

Primary outcome measure

  • Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP) [ Time Frame: 6 months post-DSLT treatment ]

Central Contacts and Locations

Central contacts

Renee Bondurant

727-450-4668Renee.Bondurant@eyespecialist.com

Locations

The Eye Institute of West Florida

Recruiting

Largo, Florida, United States, 33770

Contacts

Renee Bondurant

727-450-4668Renee.Bondurant@eyespecialist.com

Principal Investigator:

Neel Desai, MD

More Information

Sponsor

The Eye Institute of West Florida

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Eye Institute of West Florida on 2026-04-20.