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Excimer Laser Trabeculostomy Glaucoma Treatment Study (ELTGTS)

Primary Purpose

Glaucoma, Primary Open Angle

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ELIOS Procedure
Sponsored by
Elios Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site
  • Elios Vision Clinical Site 2
  • ELIOS Vision Clinical Site
  • ELIOS Vision Clinical Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ELIOS Procedure

Arm Description

ELIOS Procedure

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Mean Change in medication-free DIOP from baseline
Mean change in medication-free DIOP from baseline

Full Information

First Posted
May 19, 2021
Last Updated
August 11, 2023
Sponsor
Elios Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04899063
Brief Title
Excimer Laser Trabeculostomy Glaucoma Treatment Study
Acronym
ELTGTS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elios Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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) undergoing cataract surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELIOS Procedure
Arm Type
Other
Arm Description
ELIOS Procedure
Intervention Type
Device
Intervention Name(s)
ELIOS Procedure
Intervention Description
Treatment with the ELIOS System
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
Description
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
Time Frame
24 Month
Secondary Outcome Measure Information:
Title
Mean Change in medication-free DIOP from baseline
Description
Mean change in medication-free DIOP from baseline
Time Frame
24 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal (Ike) Ahmed, MD
Organizational Affiliation
Prism Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
ELIOS Vision Clinical Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32904
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Duncanville
State/Province
Texas
ZIP/Postal Code
75137
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Elios Vision Clinical Site 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
ELIOS Vision Clinical Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD planned to be shared with other researchers

Learn more about this trial

Excimer Laser Trabeculostomy Glaucoma Treatment Study

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