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

Not Applicable

Recruiting

• Conditions: Open Angle Glaucoma
• Interventions: Procedure: ELIOS; Procedure: Competitor Device

• Registration Number: NCT06246136
• Lead Sponsor: Elios Vision, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-05
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	ELIOS	ELIOS
Arm 2	Competitor Device	Competitor Device

Primary Outcome Measures

Name	Time	Method
PRIMARY EFFECTIVENESS ENDPOINTS : IOP	12 months	Mean change in post-washout diurnal IOP from baseline to 12 months.

Secondary Outcome Measures

Name	Time	Method
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP	24 months	Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP	12 months	Mean change in treated IOP from screening to 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications	12 months	Proportion of patients Medication free at 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications	12 months	change in number of hypotensive medications from screening to 12 months

Trial Locations

Locations (4)

ELIOS Clinical Site; 🇬🇧 London, United Kingdom

ELIOS Clincal Site; 🇪🇸 Madrid, Spain

ELIOS Clinical site; 🇪🇸 Madrid, Spain

ELIOS clinical site; 🇬🇧 London, United Kingdom