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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042755

Enrollment

Registered

2014-01-23

Start date

2014-02-28

Completion date

2016-05-31

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Cataract

Keywords

cataract, IOL, trifocal, 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.

Interventions

DEVICEtrifocal intraocular lens

Standard cataract surgery

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Visual acuity	3 months	At far, near and intermediate distance.

Secondary

Measure	Time frame	Description
Contrast sensitivity	3 months	Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026