DSLT for Reducing Medication in Glaucoma

NCT07390890 | Recruiting FDA Device

• 1 other identifier: ND-25-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  6 months post-DSLT treatment

Secondary Outcomes (3)

• Change in intraocular pressure (IOP) from baseline

  6 months post-DSLT treatment

• 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

Interventions

Voyager DSLT DEVICE

Voyager DSLT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with ocular hypertension or POAG undergoing DSLT treatment in one or both eyes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Eye Institute of West Florida: lead
• Sengi: collaborator

Study Sites (1)

The Eye Institute of West Florida

Largo, Florida, 33770, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Neel Desai, MD

  The Eye Institute of West Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee Bondurant

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)