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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voyager DSLT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP | 6 months post-DSLT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible test subjects will be 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Wright | Contact | 713-580-2500 | Melissa.Wright@manneye.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex Hacopian, MD | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Recruiting | Houston | Texas | 76134-2099 | United States |
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| 12 months post-DSLT |
| Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications | 6 months post-DSLT |
| Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications | 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 | 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 | 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 | 6 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 | 12 months post-DSLT |