Safety and Feasibility of the ELIOS System in POAG Patients

Elios Vision

Status: Enrolling

Conditions: Glaucoma, Primary Open Angle

Treatments: Device: ELIOS Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT05999006

EP-02

Details and patient eligibility

About

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)

Enrollment: 65 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

ELIOS Procedure

Experimental group

Description:

ELIOS Procedure

Treatment:

Device: ELIOS Procedure