Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL

Cataract Clinical Trial

Official title:

A Clinical Assessment of Visual Performance of Combining the Tecnis Symfony Extended Range of Vision IOL (ZXR00) With the +3.25D Tecnis Multifocal 1-Piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847572
• Other study ID #: CrystalClearVision
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: July 18, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Crystal Clear Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

Description:

Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• good general health,

• willing to comply with study instructions,

• Visual potential of 20/30 or better,

• less than 1.5D of corneal astigmatism,

• normal macula,

• clear lens or cataract,

• pupil size greater than 3.5mm

Exclusion Criteria:

• known pathology to affect visual outcome,

• amblyopia or strabismus,

• pupil abnormalities,

• zonule problems,

• keratoconus,

• no prior ocular surgery,use of medication that could affect vision,

• uncontrolled systemic disease

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Cataract Surgery
All patients wil be having intraocular lens surgery

Locations

Country	Name	City	State
Canada	Crystal Clear Vision	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Crystal Clear Vision	Abbott

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Vision will be measured at distance, intermediate and near with and without correction.	3 months
Secondary	Patient Satisfaction	Patients will fill in a Patient Satisfaction Questionnaire at all visits. Contrast sensitivity will also be measured	3 months