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OpenTrials
Completed

NCT Number: NCT02847572

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crystal Clear Vision

Toronto, Ontario, M5R 2E3, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

All patients wil be having intraocular lens surgery

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Vision will be measured at distance, intermediate and near with and without correction.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 3 months

    Patients will fill in a Patient Satisfaction Questionnaire at all visits. Contrast sensitivity will also be measured

Sponsors and collaborators

Lead sponsor

Crystal Clear Vision

Other

Collaborators

  • Abbott

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2016
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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