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:
- Male or female subjects.
- 40 years old or older.
- Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
- Visually significant cataract eligible for phacoemulsification.
Exclusion Criteria:
- All forms of angle closure glaucoma
- 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
- Congenital or developmental glaucoma
- 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)
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1
ELIOS Clinical Site
Leuven, Belgium
2
Elios Clinical Site
Avranches, France
3
ELIOS Clinical Site
Bordeaux, France
4
ELIOS clinical site
Paris, France