Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
Recruiting · NCT06246136 · Interventional (participants receive a specific treatment) · Lead sponsor: Elios Vision, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Competitor DeviceELIOS
What this trial is about
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 take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
16 locations listed.
- Elios Clinical Site - Avranches, France
- ELIOS clinical site - Barcelona, Spain
- ELIOS Clinical Site - Bochum, Germany
- Elios clinical site - Bonn, Germany
- ELIOS Clinical Site - Bordeaux, France
- ELIOS Clinical Site - East Grinstead, United Kingdom
- ELIOS Clinical Site - Edinburgh, United Kingdom
- ELIOS Clinical Site - Guildford, United Kingdom
- ELIOS clinical site - Heidelberg, Germany
- ELIOS Clinical Site - Leuven, Belgium
- ELIOS clinical site - London, United Kingdom
- ELIOS Clinical Site - Maastricht, Netherlands
- ELIOS Clincal Site - Madrid, Spain
- ELIOS Clinical site - Madrid, Spain
- ELIOS Clinical Site - Manchester, United Kingdom
- ELIOS clinical site - Paris, France