Lowering eye pressure in pigmentary glaucoma with DSLT
Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
This study will try Voyager DSLT to lower eye pressure in adults with pigmentary dispersion syndrome or mild-to-moderate pigmentary glaucoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Sex | All |
| Sponsor | Mann Eye Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07281391 on ClinicalTrials.gov |
What this trial studies
This is a single-site, single-arm, prospective observational study of Voyager DSLT with follow-up visits up to 12 months. Eligible adults will be treatment-naive or undergo medication washout and receive DSLT in the study eye, with scheduled monitoring of intraocular pressure and glaucoma medication use. Clinical evaluations include IOP measurement and counting glaucoma medications at each visit to document post-procedure changes. Eyes with prior incisional glaucoma surgery, recent laser trabeculoplasty, other secondary glaucomas, or anticipated cataract surgery during follow-up are excluded.
Who should consider this trial
Good fit: Adults with pigmentary dispersion syndrome or mild-to-moderate pigmentary glaucoma who are treatment-naive or can undergo medication washout, with IOP 18–34 mmHg and central corneal thickness 480–600 µm, are the intended participants.
Not a fit: Patients with prior incisional glaucoma surgery, recent laser trabeculoplasty, other secondary glaucomas, significant ocular inflammation/infection, or those planning cataract surgery during follow-up are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, DSLT could lower intraocular pressure and reduce the need for glaucoma medications in patients with pigmentary glaucoma.
How similar studies have performed: Conventional selective laser trabeculoplasty (SLT) has proven IOP-lowering effects in open-angle glaucomas, but DSLT is a newer modality with limited specific data in pigmentary glaucoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- Mann Eye Institute — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alex Hacopian, MD — Mann Eye Institute
- Study coordinator: Melissa Wright
- Email: Melissa.Wright@manneye.com
- Phone: 713-580-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.