IOP Reduction in Pigmentary Glaucoma Using DSLT

Mann Eye Institute

Status: Not yet enrolling

Conditions: Pigmentary Dispersion Syndrome; Pigmentary Dispersion Glaucoma

Treatments: Device: Voyager DSLT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07281391

AH-25-01

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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