Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System

Sponsor
PowerVision (Industry)
Overall Status
Completed
CT.gov ID
NCT02418871
Collaborator
(none)
53
Enrollment
5
Locations
1
Arm
41.8
Actual Duration (Months)
10.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: FluidVision AIOL
  • Procedure: Cataract surgery
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 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 With an Improved Injector System
Actual Study Start Date :
Mar 13, 2015
Actual Primary Completion Date :
Mar 16, 2016
Actual Study Completion Date :
Sep 5, 2018

Arms and Interventions

ArmIntervention/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. An improved injector system was used.

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

SiteCityStateCountryPostal Code
1PowerVision Investigative SiteBudapestHungary
2PowerVision Investigative SiteClaremontCape TownSouth Africa2001
3PowerVision Investigative SiteNorthcliffJohannesburgSouth Africa2001
4PowerVision Investigative SiteQueenswoodPretoriaSouth Africa2001
5PowerVision Investigative SiteSomerset WestSouth Africa

Sponsors and Collaborators

  • PowerVision

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PowerVision
ClinicalTrials.gov Identifier:
NCT02418871
Other Study ID Numbers:
  • AIOL-2015-1
First Posted:
Apr 16, 2015
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2021