IOP Reduction in Pigmentary Glaucoma Using DSLT

N/ANot Yet RecruitingNCT07281391

Mann Eye Institute45 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pigmentary Dispersion Syndrome Pigmentary Dispersion Glaucoma

Interventions

Voyager DSLTDEVICE

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

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Mann Eye Institute

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months post-DSLT

Secondary Outcomes

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

Time frame: 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

Time frame: 12 months post-DSLT

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

Time frame: 6 months post-DSLT

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

Time frame: 12 months post-DSLT

Change in number of glaucoma medication(s)

This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

Time frame: 6 months post-DSLT

Change in number of glaucoma medication(s)

This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

Time frame: 12 months post-DSLT

Proportion of medication free eyes post-DSLT

This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

Central Contacts

Melissa Wright

CONTACT

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

Data from ClinicalTrials.gov

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