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

CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: FluidVision AIOL; Procedure: Cataract surgery; Device: AcrySof IQ PanOptix Trifocal IOL

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Somerset West, South Africa, 7130
    • PowerVision Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Procedure: Cataract surgery; Cataract surgery per investigator's standard practice; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 6 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 6 postoperative
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.	Month 6 postoperative
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.	Month 6 postoperative

Collaborators and Investigators

• Sponsor: PowerVision

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Intraocular lens; Eye surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTP08239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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