Safety and Feasibility of the ELIOS System in POAG Patients

Glaucoma, Primary Open Angle Clinical Trial

Official title:

A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999006
• Other study ID #: EP-02
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Elios Vision, Inc.
• Contact: Rupali Nangia
• Phone: 714-227-6151
• Email: rupali[@]eliosvision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

Device:
• ELIOS Procedure
Treatment with the ELIOS System

Locations

Country	Name	City	State
United States	Elios Vision Clinical Site	Glendale	Arizona
United States	Elios Vision Clinical Site	Kenosha	Wisconsin
United States	Elios Vision Clinical Site	Largo	Florida
United States	Elios Vision Clinical Site	Oklahoma City	Oklahoma
United States	Elios Vision Clinical Site	Rock Island	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Elios Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications	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
Primary	Mean Change in DIOP from baseline on the same or fewer medications	Mean Change in DIOP from baseline on the same or fewer medications	12 Months