Clinical trial NCT02049567: Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)
Official title: Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: Cataract
Lead sponsor: PowerVision
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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 exclusion criteria may apply.

Primary outcomes:
measure: Accommodative amplitude
timeFrame: Month 6
measure: Best corrected distance visual acuity (BCDVA)
timeFrame: Month 6
measure: Rates of adverse events
timeFrame: Up to Month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: PowerVision Investigative Site
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: PowerVision Investigative Site
state: Baden-Württemberg
city: Bochum
country: Germany
facility: PowerVision Investigative Site
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: PowerVision Investigative Site
city: Claremont
country: South Africa
facility: PowerVision Investigative Site
state: Cape Town
city: Northcliff
country: South Africa
facility: PowerVision Investigative Site
state: Johannesburg
city: Queenswood
country: South Africa
facility: PowerVision Investigative Site
state: Pretoria
city: Paardevlei
country: South Africa
facility: PowerVision Investigative Site
state: Somerset West
Study officials:
References: