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

Elios Vision, Inc.6 sites in 4 countries194 target enrollmentDecember 5, 2023

ConditionsOpen Angle Glaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Open Angle Glaucoma
Sponsor: Elios Vision, Inc.
Enrollment: 194
Locations: 6
Primary Endpoint: PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 5, 2023

End Date

March 31, 2028

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Elios Vision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects.
•40 years old or older.
•Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
•Visually significant cataract eligible for phacoemulsification.

Exclusion Criteria

•All forms of angle closure glaucoma
•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
•Congenital or developmental glaucoma
•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

Outcomes

Primary Outcomes

PRIMARY EFFECTIVENESS ENDPOINTS : IOP

Time Frame: 12 months

Mean change in post-washout diurnal IOP from baseline to 12 months.

Secondary Outcomes

SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP(12 months)
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP(24 months)
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications(12 months)
SECONDARY EFFECTIVENESS ENDPOINTS : Medications(12 months)