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Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

Sponsor
PowerVision (Industry)
Overall Status
Completed
CT.gov ID
NCT02049567
Collaborator
(none)
170
Enrollment
8
Locations
1
Arm
45.7
Actual Duration (Months)
21.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: FluidVision AIOL
  • Procedure: Cataract Surgery
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
Actual Study Start Date :
Jan 14, 2014
Actual Primary Completion Date :
Jun 24, 2015
Actual Study Completion Date :
Nov 6, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Best corrected distance visual acuity (BCDVA) [Month 6]

    Visual acuity of the eye will be tested with the correction in place.

  3. Rates of adverse events [Up to Month 36]

    Adverse events will be collected from time of enrollment to study exit

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PowerVision Investigative Site Heidelberg Baden-Württemberg Germany D-69120
2 PowerVision Investigative Site Stuttgart Baden-Württemberg Germany D-70176
3 PowerVision Investigative Site Bochum North Rhine-Westphalia Germany 44892
4 PowerVision Investigative Site Berlin Germany 10559
5 PowerVision Investigative Site Claremont Cape Town South Africa 7708
6 PowerVision Investigative Site Northcliff Johannesburg South Africa 2195
7 PowerVision Investigative Site Queenswood Pretoria South Africa 2001
8 PowerVision Investigative Site Paardevlei Somerset West South Africa 7130

Sponsors and Collaborators

  • PowerVision

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PowerVision
ClinicalTrials.gov Identifier:
NCT02049567
Other Study ID Numbers:
  • AIOL-2009-1
First Posted:
Jan 30, 2014
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by PowerVision
Cataract
Additional relevant MeSH terms:
Aphakia

Study Results

No Results Posted as of May 21, 2021