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

Elios Vision

Status: Enrolling

Conditions: Open Angle Glaucoma

Treatments: Procedure: Competitor Device; Procedure: ELIOS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06246136

ELIOS-RCT STERLING

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

ELIOS

Treatment:

Procedure: ELIOS

Arm 2

Active Comparator group

Description:

Competitor Device

Treatment:

Procedure: Competitor Device