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

NCT ID: NCT02847572

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery Patient

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

Group Type: OTHER

Cataract Surgery

Intervention Type: PROCEDURE

All patients wil be having intraocular lens surgery

Interventions

Cataract Surgery

All patients wil be having intraocular lens surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Crystal Clear Vision

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sondra Black, OD

Role: STUDY_CHAIR

Crystal Clear Vision

Locations

Crystal Clear Vision

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CrystalClearVision

Identifier Type: -

Identifier Source: org_study_id