Aphakia
Conditions
Keywords
Cataract
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
Detailed description
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.
Interventions
DEVICEFluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURECataract Surgery
Performed using standard microsurgical techniques
Sponsors
PowerVision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction; * Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester); * Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism; * Willing and able to comply with schedule for follow-up visits for 36 months after surgery. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes); * Taking systemic medications that may confound the outcome or increase the risk to the subject; * Ocular conditions that may predispose for future complications; * Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject; * Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes; * Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accommodative amplitude | Month 6 | 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. |
| Best corrected distance visual acuity (BCDVA) | Month 6 | Visual acuity of the eye will be tested with the correction in place. |
| Rates of adverse events | Up to Month 36 | Adverse events will be collected from time of enrollment to study exit |
Countries
Germany, South Africa
Outcome results
None listed