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) undergoing cataract surgery
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 * Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse * Medicated IOP of \<=24 mmHg * Unmedicated diurnal IOP of \>=22 mmHg and \<=34 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 medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | 24 Month | Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in medication-free DIOP from baseline | 24 Month | Mean change in medication-free DIOP from baseline |
Countries
United States
Contacts
STUDY_DIRECTORIqbal (Ike) Ahmed, MD
Prism Eye Institute
Outcome results
None listed