The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
170
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Performed using standard microsurgical techniques
PowerVision Investigative Site
Heidelberg, Baden-Wurttemberg, Germany
PowerVision Investigative Site
Stuttgart, Baden-Wurttemberg, Germany
PowerVision Investigative Site
Bochum, North Rhine-Westphalia, Germany
PowerVision Investigative Site
Berlin, Germany
Accommodative amplitude
Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.
Time frame: Month 6
Best corrected distance visual acuity (BCDVA)
Visual acuity of the eye will be tested with the correction in place.
Time frame: Month 6
Rates of adverse events
Adverse events will be collected from time of enrollment to study exit
Time frame: Up to Month 36
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PowerVision Investigative Site
Claremont, Cape Town, South Africa
PowerVision Investigative Site
Northcliff, Johannesburg, South Africa
PowerVision Investigative Site
Queenswood, Pretoria, South Africa
PowerVision Investigative Site
Paardevlei, Somerset West, South Africa