IOP Reduction in Pigmentary Glaucoma Using DSLT

NCT07281391 | Recruiting FDA Device

• 1 other identifier: AH-25-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.

Conditions

Pigmentary Dispersion Glaucoma; Pigmentary Dispersion Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP

  6 months post-DSLT

Secondary Outcomes (8)

• Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP

  6 months post-DSLT

• Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP

  12 months post-DSLT

• Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

  6 months post-DSLT

• Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

  12 months post-DSLT

• Change in number of glaucoma medication(s)

  6 months post-DSLT

Interventions

Voyager DSLT DEVICE

DSLT is an innovative adaptation of traditional SLT. Rather than using a gonioscopic lens, DSLT applies laser energy directly through the limbus to the trabecular meshwork in a few seconds.

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

Eligible test subjects will be adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.

You may qualify if:

• Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
• Treatment naive, or washed out IOP ranging from ≥18-34 mmHg
• Central corneal thickness (CCT) 480-600 µm
• Able to complete medication washout and follow-up

You may not qualify if:

• Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
• Prior laser trabeculoplasty \<3 years
• Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years
• Patients anticipating cataract surgery within the follow-up period
• History of ocular inflammation and infection
• All other secondary glaucoma including exfoliative
• Patients unable to have DSLT treatment

Sponsors & Collaborators

• Sengi: collaborator
• Mann Eye Institute: lead

Study Sites (1)

Mann Eye Institute

Houston, Texas, 76134-2099, United States

RECRUITING

Study Officials

• Alex Hacopian, MD

  Mann Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Wright

CONTACT

713-580-2500; Melissa.Wright@manneye.com

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)