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OpenTrials
Completed

NCT Number: NCT05999006

Safety and Feasibility of the ELIOS System in POAG Patients

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)

Completed

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Key information

Conditions

Glaucoma, Primary Open Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elios Vision Clinical Site, Glendale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELIOS Procedure

Device

Treatment with the ELIOS System

Primary outcomes

  1. Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications

    Time frame: 12 Months

    Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications

  2. Mean Change in DIOP from baseline on the same or fewer medications

    Time frame: 12 Months

    Mean Change in DIOP from baseline on the same or fewer medications

Sponsors and collaborators

Lead sponsor

Elios Vision, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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