NCT02042755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

December 20, 2013

Last Update Submit

May 5, 2021

Conditions

Bilateral Cataract

Keywords

cataractIOLtrifocalFineVision

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    At far, near and intermediate distance.

    3 months

Secondary Outcomes (1)

  • Contrast sensitivity

    3 months

Interventions

trifocal intraocular lensDEVICE

Standard cataract surgery

Also known as: Physiol POD 26P AY FineVision

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cataract patients wishing high spectacle independance after the surgery

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center 49Th Jabotinsky Street

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Irit Bahar, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

January 23, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)