Safety and Feasibility of the ELIOS System in POAG Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2026-04-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Glaucoma, Primary Open Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELIOS Procedure

Group Type EXPERIMENTAL

ELIOS Procedure

Intervention Type DEVICE

Treatment with the ELIOS System

Interventions

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ELIOS Procedure

Treatment with the ELIOS System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No