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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma.
The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT.
Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voyager DSLT | Device | Voyager DSLT |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP) | The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment. | 6 months post-DSLT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intraocular pressure (IOP) from baseline | IOP will be measured using Goldmann applanation tonometry at each follow-up visit. | 6 months post-DSLT treatment |
| Proportion of eyes needing medication stratified by number of IOP medications required |
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Inclusion Criteria:
Adult patients scheduled to undergo DSLT treatment in one or both eyes.
Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.
Exclusion Criteria:
Previous glaucoma surgeries/interventions:
Patients who have undergone cataract surgery within the prior 2 years.
Secondary glaucoma:
Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.
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Adults with ocular hypertension or POAG undergoing DSLT treatment in one or both eyes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renee Bondurant | Contact | 727-450-4668 | Renee.Bondurant@eyespecialist.com |
| Name | Affiliation | Role |
|---|---|---|
| Neel Desai, MD | The Eye Institute of West Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Institute of West Florida | Recruiting | Largo | Florida | 33770 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| 6 months post-DSLT treatment |
| Number and type of Secondary surgical interventions | 6 months post-DSLT treatment |