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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.

Tracking Information
First Submitted Date December 20, 2013
First Posted Date January 23, 2014
Last Update Posted Date May 6, 2021
Study Start Date February 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2014)		 Visual acuity [ Time Frame: 3 months ]
At far, near and intermediate distance.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 20, 2014)		 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 ).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Official Title Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cataract patients wishing high spectacle independance after the surgery
Condition Bilateral Cataract
Intervention Device: trifocal intraocular lens
Standard cataract surgery
Other Name: Physiol POD 26P AY FineVision
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 18, 2017)		 19
Original Estimated Enrollment
 (submitted: January 20, 2014)		 20
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02042755
Other Study ID Numbers POD AY 26P FineVision
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Beaver-Visitec International, Inc.
Original Responsible Party Same as current
Current Study Sponsor Beaver-Visitec International, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Irit Bahar, MD Rabin Medical Center
PRS Account Beaver-Visitec International, Inc.
Verification Date May 2021