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

N/ACompletedNCT02042755

Beaver-Visitec International, Inc.19 enrolled

Overview

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.

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

Conditions

Bilateral Cataract

Interventions

trifocal intraocular lensDEVICE

Standard cataract surgery

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rabin Medical Center 49Th Jabotinsky Street

Petah Tikva, Israel

Outcomes

Primary Outcomes

Visual acuity

At far, near and intermediate distance.

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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