Safety and Feasibility of the ELIOS System in POAG Patients

Description

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)

Conditions

Glaucoma, Primary Open Angle

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Study Overview

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Study Details

Study overview

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)

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

Safety and Feasibility of the ELIOS System in POAG Patients

Condition
Glaucoma, Primary Open Angle
Intervention / Treatment

-

Contacts and Locations

Glendale

Elios Vision Clinical Site, Glendale, Arizona, United States, 85306

Largo

Elios Vision Clinical Site, Largo, Florida, United States, 33770

Rock Island

Elios Vision Clinical Site, Rock Island, Illinois, United States, 61201

Oklahoma City

Elios Vision Clinical Site, Oklahoma City, Oklahoma, United States, 73112

Kenosha

Elios Vision Clinical Site, Kenosha, Wisconsin, United States, 53142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Elios Vision, Inc.,

Iqbal (Ike) Ahmed, MD, STUDY_DIRECTOR, Prism Eye Institute

Study Record Dates

2025-10