Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

Aphakia Clinical Trial

Official title:

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049567
• Other study ID #: AIOL-2009-1
• Status: Completed
• Phase: N/A
• Start date: January 14, 2014
• Est. completion date: November 6, 2017

Study information

• Verified date: May 2021
• Source: PowerVision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.

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 information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 6, 2017
• Est. primary completion date: June 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• FluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Procedure:
• Cataract Surgery
Performed using standard microsurgical techniques

Locations

Country	Name	City	State
Germany	PowerVision Investigative Site	Berlin
Germany	PowerVision Investigative Site	Bochum	North Rhine-Westphalia
Germany	PowerVision Investigative Site	Heidelberg	Baden-Württemberg
Germany	PowerVision Investigative Site	Stuttgart	Baden-Württemberg
South Africa	PowerVision Investigative Site	Claremont	Cape Town
South Africa	PowerVision Investigative Site	Northcliff	Johannesburg
South Africa	PowerVision Investigative Site	Paardevlei	Somerset West
South Africa	PowerVision Investigative Site	Queenswood	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
PowerVision

Countries where clinical trial is conducted

Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodative amplitude	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.	Month 6
Primary	Best corrected distance visual acuity (BCDVA)	Visual acuity of the eye will be tested with the correction in place.	Month 6
Primary	Rates of adverse events	Adverse events will be collected from time of enrollment to study exit	Up to Month 36