Clinical trial NCT06246136: Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: Excimer Laser
Micro-bypass
Trabeculostomy
Lead sponsor: Elios Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 194
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: PRIMARY EFFECTIVENESS ENDPOINTS : IOP
timeFrame: 12 months
Secondary outcomes:
measure: SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
timeFrame: 24 months
measure: SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
timeFrame: 12 months
measure: SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
timeFrame: 12 months
measure: SECONDARY EFFECTIVENESS ENDPOINTS : Medications
timeFrame: 12 months
Other outcomes:
measure: SAFETY ENDPOINTS : adverse events
timeFrame: 24 months
measure: Safety endpoints: Retinal nerve fiber layer thickness
timeFrame: 12 months (with a planned extension of analysis at 24 months)
Locations:
city: Leuven
country: Belgium
facility: ELIOS Clinical Site
city: Bordeaux
country: France
facility: ELIOS Clinical Site
city: Paris
country: France
facility: ELIOS clinical site
city: Bochum
country: Germany
facility: ELIOS Clinical Site
city: Heidelberg
country: Germany
facility: ELIOS clinical site
city: Maastricht
country: Netherlands
facility: ELIOS Clinical Site
city: Barcelona
country: Spain
facility: ELIOS clinical site
city: Madrid
country: Spain
facility: ELIOS Clincal Site
city: Madrid
country: Spain
facility: ELIOS Clinical site
city: Edinburgh
country: United Kingdom
facility: ELIOS Clinical Site
city: Guildford
country: United Kingdom
facility: ELIOS Clinical Site
city: London
country: United Kingdom
facility: ELIOS clinical site
city: London
country: United Kingdom
facility: ELIOS Clinical Site
Study officials:
References: