RECRUITING

Safety and Feasibility of the ELIOS System in POAG Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

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

Quick Facts

Study Start:2023-10-18
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05999006

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.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of mild to moderate POAG
  2. * Medicated IOP of \<=24 mmHg
  3. * Shaffer angle grade of III or IV
  4. * CD ratio \<=0.8
  5. * At least 45 years old
  1. * Closed-angle and secondary glaucomas
  2. * Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
  3. * Cannot undergo medication washout in the study eye
  4. * 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

Contacts and Locations

Study Contact

Rupali Nangia
CONTACT
714-227-6151
rupali@eliosvision.com

Principal Investigator

Iqbal (Ike) Ahmed, MD
STUDY_DIRECTOR
Prism Eye Institute

Study Locations (Sites)

Elios Vision Clinical Site
Glendale, Arizona, 85306
United States
Elios Vision Clinical Site
Largo, Florida, 33770
United States
Elios Vision Clinical Site
Rock Island, Illinois, 61201
United States
Elios Vision Clinical Site
Oklahoma City, Oklahoma, 73112
United States
Elios Vision Clinical Site
Kenosha, Wisconsin, 53142
United States

Collaborators and Investigators

Sponsor: Elios Vision, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Glaucoma, Primary Open Angle