Comparing ELIOS with other devices for glaucoma patients undergoing cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness and safety of the ELIOS device in conjunction with cataract surgery for patients with open-angle glaucoma. It will compare the reduction of intraocular pressure (IOP) at 12 months post-surgery between patients using ELIOS and those using a competitor device. Participants must be 40 years or older and diagnosed with mild to moderate forms of glaucoma. The study will involve phacoemulsification with intraocular lens implantation as part of the surgical procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• ELIOS Clinical Site
  Leuven, Belgium Recruiting
• Elios Clinical Site
  Avranches, France Recruiting
• ELIOS Clinical Site
  Bordeaux, France Recruiting
• ELIOS clinical site
  Paris, France Recruiting
• ELIOS Clinical Site
  Bochum, Germany Recruiting
• Elios clinical site
  Bonn, Germany Recruiting

Study contacts

• Study coordinator: Cameron Hudson
• Email: Cameron.Hudson@bausch.com
• Phone: +33388308811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.