Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
NCT ID: NCT06246136
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
194 participants
INTERVENTIONAL
2023-12-05
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1
ELIOS
ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Arm 2
Competitor Device
Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Interventions
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ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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Elios Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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ELIOS Clinical Site
Leuven, , Belgium
Elios Clinical Site
Avranches, , France
ELIOS Clinical Site
Bordeaux, , France
ELIOS clinical site
Paris, , France
ELIOS Clinical Site
Bochum, , Germany
Elios clinical site
Bonn, , Germany
ELIOS clinical site
Heidelberg, , Germany
ELIOS Clinical Site
Maastricht, , Netherlands
ELIOS clinical site
Barcelona, , Spain
ELIOS Clincal Site
Madrid, , Spain
ELIOS Clinical site
Madrid, , Spain
ELIOS Clinical Site
East Grinstead, , United Kingdom
ELIOS Clinical Site
Edinburgh, , United Kingdom
ELIOS Clinical Site
Guildford, , United Kingdom
ELIOS clinical site
London, , United Kingdom
ELIOS Clinical Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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ELIOS-RCT STERLING
Identifier Type: -
Identifier Source: org_study_id
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