Cataract
Conditions
Keywords
Intraocular lens, Eye surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
DEVICEAcrySof IQ PanOptix Trifocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURECataract surgery
Cataract surgery per investigator's standard practice
Sponsors
PowerVision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Require cataract extraction by phacoemulsification; * Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity; * Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter. Key
Exclusion criteria
* Use of current medications that may affect accommodation or confound study results; * Systemic disease that may increase the operative risk or confound results; * Ocular conditions or degenerative disorders that may predispose the subject to future complications; * Monocular subjects or significant permanent visual function loss in 1 eye; * Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye | Month 6 postoperative | Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye | Month 6 postoperative | Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place. |
| Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye | Month 6 postoperative | Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place. |
| Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve | Month 6 postoperative | A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear. |
Countries
South Africa
Outcome results
None listed