An interventional study of FluidVision AIOL and AcrySof IQ PanOptix Trifocal IOL in Cataract, sponsored by PowerVision. Completed at 1 site in South Africa. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by PowerVision · Not applicable, Interventional, and Device feasibility
The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.
Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.
Key Inclusion Criteria:
Key Exclusion Criteria:
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Device: FluidVision AIOL · Procedure: Cataract surgery
Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Device: AcrySof IQ PanOptix Trifocal IOL · Procedure: Cataract surgery
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Also known as: PanOptix
Cataract surgery per investigator's standard practice
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Time frame: Month 6 postoperative
Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.
Time frame: Month 6 postoperative
Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Time frame: Month 6 postoperative
Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.
Time frame: Month 6 postoperative
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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