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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluidVision | Experimental | 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. |
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| PanOptix | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluidVision AIOL | Device | Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 postoperative |
| Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PowerVision Investigative Site | Somerset West | 7130 | South Africa |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| AcrySof IQ PanOptix Trifocal IOL | Device | Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject |
|
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| Cataract surgery | Procedure | Cataract surgery per investigator's standard practice |
|
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place. |
| 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. | Month 6 postoperative |