Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Aphakia
• Intervention / Treatment: Device: FluidVision AIOL; Procedure: Cataract Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10559
    • PowerVision Investigative Site
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, D-69120
      • PowerVision Investigative Site
    • Stuttgart, Baden-Württemberg, Germany, D-70176
      • PowerVision Investigative Site
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44892
      • PowerVision Investigative Site
• South Africa
  • Cape Town
    • Claremont, Cape Town, South Africa, 7708
      • PowerVision Investigative Site
  • Johannesburg
    • Northcliff, Johannesburg, South Africa, 2195
      • PowerVision Investigative Site
  • Pretoria
    • Queenswood, Pretoria, South Africa, 2001
      • PowerVision Investigative Site
  • Somerset West
    • Paardevlei, Somerset West, South Africa, 7130
      • PowerVision Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FluidVision; FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PowerVision

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2014
• Primary Completion (ACTUAL): June 24, 2015
• Study Completion (ACTUAL): November 6, 2017

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (ESTIMATE): January 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: AIOL-2009-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes