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

May 5, 2021 updated by: Beaver-Visitec International, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Rabin Medical Center 49Th Jabotinsky Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cataract patients wishing high spectacle independance after the surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 3 months
At far, near and intermediate distance.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Irit Bahar, MD, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POD AY 26P FineVision

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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