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

Bilateral Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042755
• Other study ID #: POD AY 26P FineVision
• Status: Completed
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral Cataract
• Cataract

Intervention

Device:
• trifocal intraocular lens
Standard cataract surgery

Locations

Country	Name	City	State
Israel	Rabin Medical Center 49Th Jabotinsky Street	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	At far, near and intermediate distance.	3 months
Secondary	Contrast sensitivity	Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).	3 months