Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)
Not Applicable
Completed
- Conditions
- Aphakia
- Registration Number
- NCT02049567
- Lead Sponsor
- PowerVision
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Best corrected distance visual acuity (BCDVA) Month 6 Visual acuity of the eye will be tested with the correction in place.
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.
Rates of adverse events Up to Month 36 Adverse events will be collected from time of enrollment to study exit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PowerVision Investigative Site
🇿🇦Paardevlei, Somerset West, South Africa
PowerVision Investigative Site🇿🇦Paardevlei, Somerset West, South Africa