Status:

RECRUITING

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

Lead Sponsor:

Elios Vision, Inc.

Conditions:

Open Angle Glaucoma

Eligibility:

All Genders

40+ years

Phase:

NA

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 postope...

Eligibility Criteria

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

Key Trial Info

Start Date :

December 5 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2028

Estimated Enrollment :

194 Patients enrolled

Trial Details

Trial ID

NCT06246136

Start Date

December 5 2023

End Date

March 31 2028

Last Update

November 26 2025

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

ELIOS Clinical Site

Leuven, Belgium

2

Elios Clinical Site

Avranches, France

3

ELIOS Clinical Site

Bordeaux, France

4

ELIOS clinical site

Paris, France

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