Back to resultsClinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL) (CLEAR)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
FluidVision AIOL
AcrySof IQ PanOptix Trifocal IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Cataract focused on measuring Intraocular lens, Eye surgery
Eligibility Criteria
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.
Sites / Locations
- PowerVision Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FluidVision
PanOptix
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Secondary Outcome Measures
Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.
Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03508778
Brief Title
Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)
Acronym
CLEAR
Official Title
CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PowerVision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Intraocular lens, Eye surgery
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FluidVision
Arm Type
Experimental
Arm Description
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.
Arm Title
PanOptix
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FluidVision AIOL
Intervention Description
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Device
Intervention Name(s)
AcrySof IQ PanOptix Trifocal IOL
Other Intervention Name(s)
PanOptix
Intervention Description
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery per investigator's standard practice
Primary Outcome Measure Information:
Title
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Description
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Time Frame
Month 6 postoperative
Secondary Outcome Measure Information:
Title
Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
Description
Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.
Time Frame
Month 6 postoperative
Title
Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
Description
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Time Frame
Month 6 postoperative
Title
Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
Description
A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.
Time Frame
Month 6 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
PowerVision Investigative Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)
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