Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ELIOS, Competitor Device.
- Who it may be relevant to
- Registry conditions: Open Angle Glaucoma. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Germany, Netherlands, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Procedure ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment. - Procedure Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Primary outcome measures
- PRIMARY EFFECTIVENESS ENDPOINTS : IOP [Time frame: 12 months]
Secondary outcome measures (4)
- SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP [Time frame: 24 months]
- SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications [Time frame: 12 months]
- SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP [Time frame: 12 months]
- SECONDARY EFFECTIVENESS ENDPOINTS : Medications [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 5 centers
- ELIOS Clinical Site — East Grinstead
- ELIOS Clinical Site — Edinburgh
- ELIOS Clinical Site — Guildford
- ELIOS clinical site — London
- ELIOS Clinical Site — Manchester
France · 3 centers
- Elios Clinical Site — Avranches
- ELIOS Clinical Site — Bordeaux
- ELIOS clinical site — Paris
Germany · 3 centers
- ELIOS Clinical Site — Bochum
- Elios clinical site — Bonn
- ELIOS clinical site — Heidelberg
Spain · 3 centers
- ELIOS clinical site — Barcelona
- ELIOS Clincal Site — Madrid
- ELIOS Clinical site — Madrid
Belgium · 1 center
- ELIOS Clinical Site — Leuven
Netherlands · 1 center
- ELIOS Clinical Site — Maastricht
Identifiers
NCT: NCT06246136 · ELIOS-RCT STERLING