RecruitingNot Applicable

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

Belgium, France, Germany194 participantsStarted 2023-12-05

Plain-language 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.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PRIMARY EFFECTIVENESS ENDPOINTS : IOP

Timeframe: 12 months

Trial details

NCT IDNCT06246136

SponsorElios Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Cameron Hudson

+33388308811 Cameron.Hudson@bausch.com

View on ClinicalTrials.gov More Open Angle Glaucoma trials