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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
194
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Following cataract surgery, surgeon will proceed to Competitor treatment.
ELIOS Clinical Site
Leuven, Belgium
RECRUITINGElios Clinical Site
Avranches, France
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Mean change in post-washout diurnal IOP from baseline to 12 months.
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
Time frame: 24 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
change in number of hypotensive medications from screening to 12 months
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Mean change in treated IOP from screening to 12 months
Time frame: 12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Proportion of patients Medication free at 12 months
Time frame: 12 months
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ELIOS Clinical Site
Bordeaux, France
RECRUITINGELIOS clinical site
Paris, France
RECRUITINGELIOS Clinical Site
Bochum, Germany
RECRUITINGElios clinical site
Bonn, Germany
RECRUITINGELIOS clinical site
Heidelberg, Germany
RECRUITINGELIOS Clinical Site
Maastricht, Netherlands
RECRUITINGELIOS clinical site
Barcelona, Spain
RECRUITINGELIOS Clincal Site
Madrid, Spain
RECRUITING...and 6 more locations