Status:
COMPLETED
Excimer Laser Trabeculostomy Glaucoma Treatment Study
Lead Sponsor:
Elios Vision, Inc.
Conditions:
Glaucoma, Primary Open Angle
Eligibility:
All Genders
45+ years
Phase:
NA
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 cata...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2025
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT04899063
Start Date
May 10 2021
End Date
July 29 2025
Last Update
September 30 2025
Active Locations (20)
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1
ELIOS Vision Clinical Site
Glendale, Arizona, United States, 85306
2
ELIOS Vision Clinical Site
Petaluma, California, United States, 94954
3
ELIOS Vision Clinical Site
Fort Collins, Colorado, United States, 80528
4
ELIOS Vision Clinical Site
Grand Junction, Colorado, United States, 81501