Recruiting NCT07281391
IOP Reduction in Pigmentary Glaucoma Using DSLT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Voyager DSLT.
- Who it may be relevant to
- Registry conditions: Pigmentary Dispersion Syndrome, Pigmentary Dispersion Glaucoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
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.
Interventions
- Device Voyager 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.
Primary outcome measures
- Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP [Time frame: 6 months post-DSLT]
Secondary outcome measures (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 [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) [Time frame: 6 months post-DSLT]
- Change in number of glaucoma medication(s) [Time frame: 12 months post-DSLT]
- Proportion of medication free eyes post-DSLT [Time frame: 6 months post-DSLT]
- Proportion of medication free eyes post-DSLT [Time frame: 12 months post-DSLT]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mann Eye Institute — Houston
Identifiers
NCT: NCT07281391 · AH-25-01