Glaucoma, Primary Open Angle
Conditions
Brief summary
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)
Interventions
DEVICEELIOS Procedure
Treatment with the ELIOS System
Sponsors
Elios Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild to moderate POAG * Medicated IOP of \<=24 mmHg * Shaffer angle grade of III or IV * CD ratio \<=0.8 * At least 45 years old
Exclusion criteria
* Closed-angle and secondary glaucomas * Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * Cannot undergo medication washout in the study eye * Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications | 12 Months | Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications |
| Mean Change in DIOP from baseline on the same or fewer medications | 12 Months | Mean Change in DIOP from baseline on the same or fewer medications |
Countries
United States
Contacts
STUDY_DIRECTORIqbal (Ike) Ahmed, MD
Prism Eye Institute
Outcome results
None listed