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Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)

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: NCT02042755
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Beaver-Visitec International, Inc.

Study Description
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Brief Summary:

The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.

Secondary objective will be to test the glare and contrast sensitivity.


Condition or disease Intervention/treatment
Bilateral Cataract Device: trifocal intraocular lens

Detailed Description:

This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.

Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.

Study Design
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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Study Start Date : February 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Intervention Details:
  • Device: trifocal intraocular lens
    Standard cataract surgery
    Other Name: Physiol POD 26P AY FineVision

Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 months ]
    At far, near and intermediate distance.


Secondary Outcome Measures :
  1. Contrast sensitivity [ Time Frame: 3 months ]
    Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cataract patients wishing high spectacle independance after the surgery
Criteria

Inclusion Criteria:

  • - Age-related cataract
  • Preoperative Corneal astigmatism < 0.75 D
  • Age 21 and older
  • Visual Acuity > 0.05
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
  • Patient willing multifocal implantation and with realistic expectations.

Exclusion Criteria:

  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
  • Previous ocular surgery or trauma.
Contacts and Locations
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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): NCT02042755


Locations
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Israel
Rabin Medical Center 49Th Jabotinsky Street
Petach Tikva, Israel
Sponsors and Collaborators
Beaver-Visitec International, Inc.
Investigators
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Principal Investigator: Irit Bahar, MD Rabin Medical Center
More Information
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Responsible Party: Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier: NCT02042755    
Other Study ID Numbers: POD AY 26P FineVision
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Beaver-Visitec International, Inc.:
cataract
IOL
trifocal
FineVision
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases