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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Cataract Surgery

• Registration Number: NCT02847572
• Lead Sponsor: Crystal Clear Vision

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery Patient	Cataract Surgery	All patients to be implanted bilaterally with a Tecnis Extended Range Lens in the Dominant eye and a Low Add Multifocal in the non dominant

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Vision will be measured at distance, intermediate and near with and without correction.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	3 months	Patients will fill in a Patient Satisfaction Questionnaire at all visits. Contrast sensitivity will also be measured

Trial Locations

Locations (1)

Crystal Clear Vision; 🇨🇦 Toronto, Ontario, Canada