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

Completed

• Conditions: Bilateral Cataract

• Registration Number: NCT02042755
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Study Start: 2014-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	3 months	At far, near and intermediate distance.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rabin Medical Center 49Th Jabotinsky Street; 🇮🇱 Petach Tikva, Israel