Clincosm LogoSign in Get a demo

CLEAR: Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

Sponsor
PowerVision (Industry)
Overall Status
Completed
CT.gov ID
NCT03508778
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
21.3
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.

Condition or Disease Intervention/Treatment Phase
  • Device: FluidVision AIOL
  • Device: AcrySof IQ PanOptix Trifocal IOL
  • Procedure: Cataract surgery
 N/A

Detailed Description

Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Device Feasibility
Official Title:
CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
Actual Study Start Date :
Feb 27, 2018
Actual Primary Completion Date :
Jun 11, 2019
Actual Study Completion Date :
Dec 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: FluidVision

FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

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

Procedure: Cataract surgery
Cataract surgery per investigator's standard practice
Active Comparator: PanOptix

Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

Device: AcrySof IQ PanOptix Trifocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Other Names:
  • PanOptix

    • Procedure: Cataract surgery
    Cataract surgery per investigator's standard practice

    Outcome Measures

    Primary Outcome Measures

    1. Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye [Month 6 postoperative]

      Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.

    Secondary Outcome Measures

    1. Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye [Month 6 postoperative]

      Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.

    2. Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye [Month 6 postoperative]

      Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.

    3. Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve [Month 6 postoperative]

      A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Require cataract extraction by phacoemulsification;

    • Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;

    • Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.

    Key Exclusion Criteria:

    • Use of current medications that may affect accommodation or confound study results;

    • Systemic disease that may increase the operative risk or confound results;

    • Ocular conditions or degenerative disorders that may predispose the subject to future complications;

    • Monocular subjects or significant permanent visual function loss in 1 eye;

    • Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PowerVision Investigative Site 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:
    NCT03508778
    Other Study ID Numbers:
    • CTP08239
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    May 24, 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
    Intraocular lens
    Eye surgery
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of May 24, 2021