Excimer Laser Trabeculostomy Glaucoma Treatment Study

Glaucoma, Primary Open Angle Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04899063
• Other study ID #: EP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Elios Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 318
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

Device:
• ELIOS Procedure
Treatment with the ELIOS System

Locations

Country	Name	City	State
United States	ELIOS Vision Clinical Site	Chaska	Minnesota
United States	ELIOS Vision Clinical Site	DeLand	Florida
United States	ELIOS Vision Clinical Site	Duncanville	Texas
United States	ELIOS Vision Clinical Site	El Paso	Texas
United States	ELIOS Vision Clinical Site	Fort Collins	Colorado
United States	ELIOS Vision Clinical Site	Glendale	Arizona
United States	ELIOS Vision Clinical Site	Grand Junction	Colorado
United States	ELIOS Vision Clinical Site	Kenosha	Wisconsin
United States	ELIOS Vision Clinical Site	Largo	Florida
United States	ELIOS Vision Clinical Site	Las Vegas	Nevada
United States	ELIOS Vision Clinical Site	Melbourne	Florida
United States	ELIOS Vision Clinical Site	Oklahoma City	Oklahoma
United States	ELIOS Vision Clinical Site	Overland Park	Kansas
United States	ELIOS Vision Clinical Site	Petaluma	California
United States	ELIOS Vision Clinical Site	Rock Island	Illinois
United States	ELIOS Vision Clinical Site	Saint Louis	Missouri
United States	ELIOS Vision Clinical Site	San Antonio	Texas
United States	Elios Vision Clinical Site 2	San Antonio	Texas
United States	ELIOS Vision Clinical Site	South Orange	New Jersey
United States	ELIOS Vision Clinical Site	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Elios Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change in medication-free DIOP from baseline	Mean change in medication-free DIOP from baseline	24 Month