Pigmentary Dispersion Glaucoma, Pigmentary Dispersion Syndrome
Conditions
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.
Interventions
DEVICEVoyager DSLT
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.
Sponsors
Mann Eye Institute
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP | 6 months post-DSLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications | 6 months post-DSLT | — |
| Change in number of glaucoma medication(s) | 6 months post-DSLT | This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT |
| Proportion of medication free eyes post-DSLT | 6 months post-DSLT | This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT |
Countries
United States
Contacts
CONTACTMelissa Wright
PRINCIPAL_INVESTIGATORAlex Hacopian, MD
Mann Eye Institute
Outcome results
None listed