Excimer Laser Trabeculostomy Glaucoma Treatment Study (ELTGTS)

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery

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) undergoing cataract surgery

Study Overview

• Status: Completed
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Device: ELIOS Procedure

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • ELIOS Vision Clinical Site
  • California
    • Petaluma, California, United States, 94954
      • ELIOS Vision Clinical Site
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • ELIOS Vision Clinical Site
    • Grand Junction, Colorado, United States, 81501
      • ELIOS Vision Clinical Site
  • Florida
    • DeLand, Florida, United States, 32720
      • ELIOS Vision Clinical Site
    • Largo, Florida, United States, 33770
      • ELIOS Vision Clinical Site
    • Melbourne, Florida, United States, 32904
      • ELIOS Vision Clinical Site
    • Vero Beach, Florida, United States, 32960
      • ELIOS Vision Clinical Site
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • ELIOS Vision Clinical Site
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • ELIOS Vision Clinical Site
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • ELIOS Vision Clinical Site
  • Missouri
    • St Louis, Missouri, United States, 63131
      • ELIOS Vision Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • ELIOS Vision Clinical Site
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • ELIOS Vision Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • ELIOS Vision Clinical Site
  • Texas
    • Duncanville, Texas, United States, 75137
      • ELIOS Vision Clinical Site
    • El Paso, Texas, United States, 79902
      • ELIOS Vision Clinical Site
    • San Antonio, Texas, United States, 78229
      • ELIOS Vision Clinical Site
    • San Antonio, Texas, United States, 78229
      • Elios Vision Clinical Site 2
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • ELIOS Vision Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of mild to moderate POAG
• Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
• Medicated IOP of <=24 mmHg
• Unmedicated diurnal IOP of >=22 mmHg and <=34 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ELIOS Procedure	Device: ELIOS Procedure; Treatment with the ELIOS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%	Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%	24 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in medication-free DIOP from baseline	Mean change in medication-free DIOP from baseline	24 Month

Collaborators and Investigators

• Sponsor: Elios Vision, Inc.
• Investigators: Study Director: Iqbal (Ike) Ahmed, MD, Prism Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: EP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD planned to be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No