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

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02042755
Collaborator
(none)
19
1
26.9
0.7

Study Details

Study Description

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 Phase
  • 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

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 :
Feb 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [3 months]

    At far, near and intermediate distance.

Secondary Outcome Measures

  1. Contrast sensitivity [3 months]

    Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rabin Medical Center 49Th Jabotinsky Street Petach Tikva Israel

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT02042755
Other Study ID Numbers:
  • POD AY 26P FineVision
First Posted:
Jan 23, 2014
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Beaver-Visitec International, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2021