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
1 other identifier
interventional
318
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2021
CompletedFirst Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2025
CompletedSeptember 30, 2025
September 1, 2025
4.2 years
May 19, 2021
September 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Change in medication-free DIOP from baseline
24 Month
Study Arms (1)
ELIOS Procedure
OTHERELIOS Procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
ELIOS Vision Clinical Site
Glendale, Arizona, 85306, United States
ELIOS Vision Clinical Site
Petaluma, California, 94954, United States
ELIOS Vision Clinical Site
Fort Collins, Colorado, 80528, United States
ELIOS Vision Clinical Site
Grand Junction, Colorado, 81501, United States
ELIOS Vision Clinical Site
DeLand, Florida, 32720, United States
ELIOS Vision Clinical Site
Largo, Florida, 33770, United States
ELIOS Vision Clinical Site
Melbourne, Florida, 32904, United States
ELIOS Vision Clinical Site
Vero Beach, Florida, 32960, United States
ELIOS Vision Clinical Site
Rock Island, Illinois, 61201, United States
ELIOS Vision Clinical Site
Overland Park, Kansas, 66213, United States
ELIOS Vision Clinical Site
Chaska, Minnesota, 55318, United States
ELIOS Vision Clinical Site
St Louis, Missouri, 63131, United States
ELIOS Vision Clinical Site
Las Vegas, Nevada, 89145, United States
ELIOS Vision Clinical Site
South Orange, New Jersey, 07079, United States
ELIOS Vision Clinical Site
Oklahoma City, Oklahoma, 73112, United States
ELIOS Vision Clinical Site
Duncanville, Texas, 75137, United States
ELIOS Vision Clinical Site
El Paso, Texas, 79902, United States
Elios Vision Clinical Site 2
San Antonio, Texas, 78229, United States
ELIOS Vision Clinical Site
San Antonio, Texas, 78229, United States
ELIOS Vision Clinical Site
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iqbal (Ike) Ahmed, MD
Prism Eye Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 24, 2021
Study Start
May 10, 2021
Primary Completion
July 29, 2025
Study Completion
July 29, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
No IPD planned to be shared with other researchers