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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
ELIOS Clinical Site
RECRUITING
Leuven
France
Elios Clinical Site
RECRUITING
Avranches
ELIOS Clinical Site
RECRUITING
Bordeaux
ELIOS clinical site
RECRUITING
Paris
Germany
ELIOS Clinical Site
RECRUITING
Bochum
Elios clinical site
RECRUITING
Bonn
ELIOS clinical site
RECRUITING
Heidelberg
Netherlands
ELIOS Clinical Site
RECRUITING
Maastricht
Spain
ELIOS clinical site
RECRUITING
Barcelona
ELIOS Clincal Site
RECRUITING
Madrid
ELIOS Clinical site
RECRUITING
Madrid
United Kingdom
ELIOS Clinical Site
RECRUITING
Edinburgh
ELIOS Clinical Site
RECRUITING
Guildford
ELIOS clinical site
RECRUITING
London
ELIOS Clinical Site
RECRUITING
London
Contact Information
Primary
Amandine Jacques
amandine@eliosvision.com
+33670612439
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 194
Treatments
Active_comparator: Arm 1
ELIOS
Active_comparator: Arm 2
Competitor Device
Related Therapeutic Areas
Sponsors
Leads: Elios Vision, Inc.