RECRUITINGINTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
PROCEDURE
Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.
Locations (16)
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