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

NCT ID: NCT06246136

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2028-03-31

Brief Summary

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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

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Conditions

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Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

ELIOS

Group Type ACTIVE_COMPARATOR

ELIOS

Intervention Type PROCEDURE

Following cataract surgery, surgeon will proceed to ELIOS treatment.

Arm 2

Competitor Device

Group Type ACTIVE_COMPARATOR

Competitor Device

Intervention Type PROCEDURE

Following cataract surgery, surgeon will proceed to Competitor treatment.

Interventions

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ELIOS

Following cataract surgery, surgeon will proceed to ELIOS treatment.

Intervention Type PROCEDURE

Competitor Device

Following cataract surgery, surgeon will proceed to Competitor treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elios Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ELIOS Clinical Site

Leuven, , Belgium

Site Status RECRUITING

Elios Clinical Site

Avranches, , France

Site Status RECRUITING

ELIOS Clinical Site

Bordeaux, , France

Site Status RECRUITING

ELIOS clinical site

Paris, , France

Site Status RECRUITING

ELIOS Clinical Site

Bochum, , Germany

Site Status RECRUITING

Elios clinical site

Bonn, , Germany

Site Status RECRUITING

ELIOS clinical site

Heidelberg, , Germany

Site Status RECRUITING

ELIOS Clinical Site

Maastricht, , Netherlands

Site Status RECRUITING

ELIOS clinical site

Barcelona, , Spain

Site Status RECRUITING

ELIOS Clincal Site

Madrid, , Spain

Site Status RECRUITING

ELIOS Clinical site

Madrid, , Spain

Site Status RECRUITING

ELIOS Clinical Site

East Grinstead, , United Kingdom

Site Status RECRUITING

ELIOS Clinical Site

Edinburgh, , United Kingdom

Site Status RECRUITING

ELIOS Clinical Site

Guildford, , United Kingdom

Site Status RECRUITING

ELIOS clinical site

London, , United Kingdom

Site Status RECRUITING

ELIOS Clinical Site

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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Belgium France Germany Netherlands Spain United Kingdom

Central Contacts

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Cameron Hudson

Role: CONTACT

+33388308811

Facility Contacts

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Role: primary

+32 16 33 23 70

Role: primary

0033 233686000

Role: primary

0033 556795679

Role: primary

0033 148036565

Role: primary

+49 234 299 0

Role: primary

+49 228 28715505

Role: primary

+49 6221 56 6999

Role: primary

31 43 387 6800

Role: primary

+34 936 11 80 24

Role: primary

+34 915 42 60 10

Role: primary

+34 913 30 30 00

Role: primary

+44 1342 414000

Role: primary

+44 131 537 1340

Role: primary

+44 1483 571122

Role: primary

00442072533411

Role: primary

44 161 276 5522

Other Identifiers

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ELIOS-RCT STERLING

Identifier Type: -

Identifier Source: org_study_id

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