Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

Open Angle Glaucoma Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246136
• Other study ID #: ELIOS-RCT STERLING
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Elios Vision, Inc.
• Contact: Amandine Jacques
• Phone: +33670612439
• Email: amandine[@]eliosvision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects.

2. 40 years old or older.

3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:

4. Visually significant cataract eligible for phacoemulsification.

Exclusion Criteria:

1. All forms of angle closure glaucoma

2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure

3. Congenital or developmental glaucoma

4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Procedure:
• ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
• Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.

Locations

Country	Name	City	State
France	ELIOS Clinical Site	Bordeaux
France	ELIOS clinical site	Paris
Spain	ELIOS clinical site	Barcelona
Spain	ELIOS Clincal Site	Madrid
Spain	ELIOS Clinical site	Madrid
United Kingdom	ELIOS clinical site	London

Sponsors (1)

Lead Sponsor	Collaborator
Elios Vision, Inc.

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAFETY ENDPOINTS : adverse events	Rates of ocular adverse events	24 months
Other	Safety endpoints: Retinal nerve fiber layer thickness	measurement of Retinal nerve fiber layer thickness	12 months (with a planned extension of analysis at 24 months)
Primary	PRIMARY EFFECTIVENESS ENDPOINTS : IOP	Mean change in post-washout diurnal IOP from baseline to 12 months.	12 months
Secondary	SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP	Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.	24 months
Secondary	SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications	change in number of hypotensive medications from screening to 12 months	12 months
Secondary	SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP	Mean change in treated IOP from screening to 12 months	12 months
Secondary	SECONDARY EFFECTIVENESS ENDPOINTS : Medications	Proportion of patients Medication free at 12 months	12 months