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

Recruiting now · Not applicable

Conditions studied: Open Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT06246136

Run by

Elios Vision, Inc.

People needed

194

Starts

2023-12-05

Expected to finish

2028-12-01

Last updated by the study team

2026-06-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ELIOS Clinical Site — Leuven, Belgium (enrolling)
• Elios Clinical Site — Avranches, France (enrolling)
• ELIOS Clinical Site — Bordeaux, France (enrolling)
• ELIOS clinical site — Paris, France (enrolling)
• ELIOS Clinical Site — Bochum, Germany (enrolling)
• Elios clinical site — Bonn, Germany (enrolling)
• ELIOS clinical site — Heidelberg, Germany (enrolling)
• ELIOS Clinical Site — Maastricht, Netherlands (enrolling)
• ELIOS clinical site — Barcelona, Spain (enrolling)
• ELIOS Clincal Site — Madrid, Spain (enrolling)
• ELIOS Clinical site — Madrid, Spain (enrolling)
• ELIOS Clinical Site — East Grinstead, United Kingdom (enrolling)
• ELIOS Clinical Site — Edinburgh, United Kingdom (enrolling)
• ELIOS Clinical Site — Guildford, United Kingdom (enrolling)
• ELIOS clinical site — London, United Kingdom (enrolling)
• ELIOS Clinical Site — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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