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CompletedNCT02042755Updated May 6, 2021

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

An observational study in Bilateral Cataract, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Israel. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-05-06.

Sponsored by Beaver-Visitec International, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
19
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bilateral Cataract

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Keywords

  • cataract
  • IOL
  • trifocal
  • FineVision
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 19 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cataract patients wishing high spectacle independance after the surgery

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Interventions

  • Devicetrifocal intraocular lens

    Standard cataract surgery

    Also known as: Physiol POD 26P AY FineVision

06

What researchers measure

Primary outcomes

  1. Visual acuity

    At far, near and intermediate distance.

    Time frame: 3 months

Secondary outcomes

  1. Contrast sensitivity

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

    Time frame: 3 months

07

Study locations

1 site
  • Rabin Medical Center 49Th Jabotinsky Street
    Petach Tikva, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02042755
Lead sponsor
Beaver-Visitec International, Inc.
Responsible party
Sponsor
First posted
Jan 23, 2014
Start date
Feb 2014
Primary completion
May 2016
Completion
May 2016
Last update
May 6, 2021

Study contacts

Irit Bahar, MD
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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