Back to resultsEvaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System
Primary Purpose
Aphakia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FluidVision AIOL
Cataract surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Aphakia focused on measuring Cataract
Eligibility Criteria
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.
Sites / Locations
- PowerVision Investigative Site
- PowerVision Investigative Site
- PowerVision Investigative Site
- PowerVision Investigative Site
- PowerVision Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FluidVision
Arm Description
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery
Outcomes
Primary Outcome Measures
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.
Best corrected distance visual acuity (BCDVA)
Visual acuity of the eye will be tested with the correction in place.
Rates of adverse events
Adverse events will be collected from time of enrollment to study exit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02418871
Brief Title
Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System
Official Title
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens With an Improved Injector System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2015 (Actual)
Primary Completion Date
March 16, 2016 (Actual)
Study Completion Date
September 5, 2018 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
Cataract
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (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
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. An improved injector system was used.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Performed using standard microsurgical techniques
Primary Outcome Measure Information:
Title
Accommodative amplitude
Description
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.
Time Frame
Month 6
Title
Best corrected distance visual acuity (BCDVA)
Description
Visual acuity of the eye will be tested with the correction in place.
Time Frame
Month 6
Title
Rates of adverse events
Description
Adverse events will be collected from time of enrollment to study exit.
Time Frame
Up to Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
PowerVision Investigative Site
City
Budapest
Country
Hungary
Facility Name
PowerVision Investigative Site
City
Claremont
State/Province
Cape Town
ZIP/Postal Code
2001
Country
South Africa
Facility Name
PowerVision Investigative Site
City
Northcliff
State/Province
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
PowerVision Investigative Site
City
Queenswood
State/Province
Pretoria
ZIP/Postal Code
2001
Country
South Africa
Facility Name
PowerVision Investigative Site
City
Somerset West
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System
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