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

Last updated: February 6, 2025
Sponsor: Elios Vision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Vision Loss

Treatment

Competitor Device

ELIOS

iStent inject W

Clinical Study ID

NCT06246136
ELIOS-RCT STERLING
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects.

  2. 40 years old or older.

  3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliationglaucoma or pigmentary glaucoma:

  4. Visually significant cataract eligible for phacoemulsification.

Exclusion

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, andglaucoma associated with increased episcleral venous pressure

  3. Congenital or developmental glaucoma

  4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment ofany type with the exception of selective laser trabeculoplasty (SLT) occurring aminimum of 6 months prior to the Screening visit

Study Design

Total Participants: 194
Treatment Group(s): 3
Primary Treatment: Competitor Device
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • ELIOS Clinical Site

    Leuven,
    Belgium

    Active - Recruiting

  • ELIOS Clinical Site

    Bordeaux,
    France

    Active - Recruiting

  • ELIOS clinical site

    Paris,
    France

    Active - Recruiting

  • ELIOS Clinical Site

    Bochum,
    Germany

    Active - Recruiting

  • ELIOS clinical site

    Heidelberg,
    Germany

    Active - Recruiting

  • ELIOS Clinical Site

    Maastricht,
    Netherlands

    Active - Recruiting

  • ELIOS clinical site

    Barcelona,
    Spain

    Active - Recruiting

  • ELIOS Clincal Site

    Madrid,
    Spain

    Active - Recruiting

  • ELIOS Clinical site

    Madrid,
    Spain

    Active - Recruiting

  • ELIOS Clinical Site

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • ELIOS Clinical Site

    Guildford,
    United Kingdom

    Active - Recruiting

  • ELIOS Clinical Site

    London,
    United Kingdom

    Active - Recruiting

  • ELIOS clinical site

    London,
    United Kingdom

    Active - Recruiting

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