RecruitingNot ApplicableNCT06246136
Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
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
Sponsor
Elios Vision, Inc.
Enrollment
194 participants
Start Date
Dec 5, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 40 Years
Inclusion Criteria4
- Male or female subjects.
- 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 Criteria4
- 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
Interventions
PROCEDUREELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
PROCEDURECompetitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT06246136
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