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Clinical Evaluation of the FluidVision™ Accommodating Intraocular Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049567
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
PowerVision

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the investigational FluidVision® Accommodating Intraocular Lens (AIOL) to provide distance, intermediate, and near vision.

Condition or disease Intervention/treatment Phase
Aphakia Device: FluidVision AIOL Not Applicable

Detailed Description:

Eligible subjects will receive the investigational AIOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.

This study was designed and conducted by PowerVision, Inc. Alcon Research, LLC, acquired PowerVision, Inc., in 2019.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the FluidVision™ Accommodating Intraocular Lens
Actual Study Start Date : January 14, 2014
Actual Primary Completion Date : June 24, 2015
Actual Study Completion Date : November 6, 2017

Arm Intervention/treatment
Experimental: FluidVision AIOL
FluidVision AIOL implanted in the capsular bag following removal of the cataractous lens
Device: FluidVision AIOL
Accommodating intraocular lens designed to restore visual function at all distances using the eye's natural accommodative forces, intended for lifetime use
Other Name: FluidVision ME




Primary Outcome Measures :
  1. Objective accommodative amplitude (calculated at the IOL plane) [ Time Frame: 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 with good visual acuity. Objective accommodation (at the IOL plane) will be assessed using data generated by a photorefractor that analyzes the change in the refractive state of the eye.

  2. Best corrected distance visual acuity (BCDVA) of logMAR of 0.3 or better [ Time Frame: Month 6 ]
    Visual acuity of the eye will be tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing.

  3. Rates of adverse events [ Time Frame: Up to Month 36 ]
    Adverse events will be collected from time of enrollment to study exit



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
  • Predicted best corrected distance visual acuity of 20/40 or better after cataract removal and AIOL implantation as determined by potential acuity meter (PAM) or other potential vision tests or surgeon estimation on both eyes;
  • 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:

  • Taking medications that may affect accommodation;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049567


Locations
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Germany
PowerVision Investigative Site
Heidelberg, Baden-Württemberg, Germany, D-69120
PowerVision Investigative Site
Stuttgart, Baden-Württemberg, Germany, D-70176
PowerVision Investigative Site
Bochum, North Rhine-Westphalia, Germany, 44892
PowerVision Investigative Site
Berlin, Germany, 10559
South Africa
PowerVision Investigative Site
Claremont, Cape Town, South Africa, 7708
PowerVision Investigative Site
Northcliff, Johannesburg, South Africa, 2195
PowerVision Investigative Site
Queenswood, Pretoria, South Africa, 2001
PowerVision Investigative Site
Paardevlei, Somerset West, South Africa, 7130
Sponsors and Collaborators
PowerVision
Investigators
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Study Director: Sr. Clinical Trial Lead, CDMA Surgical Alcon Research, LLC
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Responsible Party: PowerVision
ClinicalTrials.gov Identifier: NCT02049567    
Other Study ID Numbers: AIOL-2009-1
CTP07752 ( Other Identifier: PowerVision, Inc. )
AIOL-2012-1 ( Other Identifier: PowerVision, Inc. )
CTP06305 ( Other Identifier: PowerVision, Inc. )
CTP01725 ( Other Identifier: PowerVision, Inc. )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by PowerVision:
Cataract
Additional relevant MeSH terms:
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Aphakia
Lens Diseases
Eye Diseases