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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
Crystal Clear Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Crystal Clear Vision

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgery Patient

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2016
Last Updated
July 18, 2017
Sponsor
Crystal Clear Vision
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT02847572
Brief Title
Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crystal Clear Vision
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery Patient
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
All patients wil be having intraocular lens surgery
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Vision will be measured at distance, intermediate and near with and without correction.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patients will fill in a Patient Satisfaction Questionnaire at all visits. Contrast sensitivity will also be measured
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sondra Black, OD
Organizational Affiliation
Crystal Clear Vision
Official's Role
Study Chair
Facility Information:
Facility Name
Crystal Clear Vision
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5R 2E3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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