RecruitingNot ApplicableNCT06246136

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

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


Sponsor

Elios Vision, Inc.

Enrollment

194 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing the effectiveness and safety of a glaucoma treatment called ELIOS — a minimally invasive procedure performed at the same time as cataract surgery — in real-world patients. Glaucoma is a condition where increased pressure in the eye damages the optic nerve. **You may be eligible if...** - You are 40 years old or older - You have mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma - You have a visually significant cataract and are scheduled for cataract removal surgery (phacoemulsification) **You may NOT be eligible if...** - You have closed-angle glaucoma - Your glaucoma is caused by another medical condition (secondary glaucoma from trauma, inflammation, steroids, or vascular disease) - You were born with glaucoma (congenital) - You have had prior eye surgery for glaucoma (with the exception of laser trabeculoplasty done at least 6 months ago) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREELIOS

Following cataract surgery, surgeon will proceed to ELIOS treatment.

PROCEDURECompetitor Device

Following cataract surgery, surgeon will proceed to Competitor treatment.


Locations(16)

ELIOS Clinical Site

Leuven, Belgium

Elios Clinical Site

Avranches, France

ELIOS Clinical Site

Bordeaux, France

ELIOS clinical site

Paris, France

ELIOS Clinical Site

Bochum, Germany

Elios clinical site

Bonn, Germany

ELIOS clinical site

Heidelberg, Germany

ELIOS Clinical Site

Maastricht, Netherlands

ELIOS clinical site

Barcelona, Spain

ELIOS Clincal Site

Madrid, Spain

ELIOS Clinical site

Madrid, Spain

ELIOS Clinical Site

East Grinstead, United Kingdom

ELIOS Clinical Site

Edinburgh, United Kingdom

ELIOS Clinical Site

Guildford, United Kingdom

ELIOS clinical site

London, United Kingdom

ELIOS Clinical Site

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06246136


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