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Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population (BUICK)

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acuvue Oasys for Presbyopia
PureVision2 for Presbyopia
Biofinity Multifocal
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Presbyopia

Eligibility Criteria

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

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  1. Is at least 42 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Has previous experience with wearing MF CLs;
  5. Is able to be successfully fitted with all study lenses;
  6. Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes;
  7. Has a spectacle cylinder ≤0.75D in both eyes;
  8. Requires a reading addition of ≥+1.00D;

Exclusion Criteria:

A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Has monocular best-corrected VA of worse than 20/30 in each eye;
  10. Has amblyopia or strabismus;

  11. Has anisometropia >2D between both eyes

    • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Acuvue Oasys for Presbyopia

PureVision2 for Presbyopia

Biofinity Multifocal

Arm Description

Acuvue Oasys for Presbyopia contact lenses worn

PureVision2 for Presbyopia contact lenses worn

Biofinity Multifocal contact lenses worn

Outcomes

Primary Outcome Measures

Decentration
Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.

Secondary Outcome Measures

Visual Acuity (high contrast) at distance
Visual Acuity (high contrast) (logMAR) at distance 6m
Visual Acuity (high contrast) at intermediate distance
Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
Visual Acuity (high contrast) at near
Visual Acuity (high contrast) (logMAR) at near (0.4m)
Visual Acuity (low contrast) at distance
Visual Acuity (low contrast) at distance 6m
Visual Acuity (low contrast) at intermediate distance
Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
Visual Acuity (low contrast) at near
Visual Acuity (low contrast) (logMAR) at near (0.4m)
Overall subjective rating of lens performance in real world tasks
Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.
Ocular aberrometry
Ocular aberrometry as measured by a LADARWave aberrometer

Full Information

First Posted
August 26, 2014
Last Updated
May 28, 2015
Sponsor
University of Waterloo
Collaborators
Johnson & Johnson Vision Care
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1. Study Identification

Unique Protocol Identification Number
NCT02228109
Brief Title
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population
Acronym
BUICK
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Johnson & Johnson Vision Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to use a corneal topographer, a device that is readily available in most optometric practices, in order to determine the position of the multifocal (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this study is to evaluate if there is a relationship between the positioning of the optics of the study lenses and the objective and subjective visual performance as well as participant satisfaction. The MF CL lenses will be fitted to two groups of participants (previously unsuccessful vs. currently successful MF CL wearers). HYPOTHESES The measurement of the power distribution acquired from the Medmont E300 corneal topographer is effective in determining MF CL lens centration and is a predictor of MF CL success. There is a difference in MF CL centration, determined by corneal topography, between successful and unsuccessful MF CL wearers. MF CL centration, determined by corneal topography, is correlated with visual performance, determined by ocular aberrometry, measures of visual acuity and subjective satisfaction.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acuvue Oasys for Presbyopia
Arm Type
Experimental
Arm Description
Acuvue Oasys for Presbyopia contact lenses worn
Arm Title
PureVision2 for Presbyopia
Arm Type
Experimental
Arm Description
PureVision2 for Presbyopia contact lenses worn
Arm Title
Biofinity Multifocal
Arm Type
Experimental
Arm Description
Biofinity Multifocal contact lenses worn
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys for Presbyopia
Intervention Description
Acuvue Oasys for Presbyopia contact lenses worn
Intervention Type
Device
Intervention Name(s)
PureVision2 for Presbyopia
Intervention Description
PureVision2 for Presbyopia contact lenses worn
Intervention Type
Device
Intervention Name(s)
Biofinity Multifocal
Intervention Description
Biofinity Multifocal contact lenses worn
Primary Outcome Measure Information:
Title
Decentration
Description
Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Visual Acuity (high contrast) at distance
Description
Visual Acuity (high contrast) (logMAR) at distance 6m
Time Frame
Day 1
Title
Visual Acuity (high contrast) at intermediate distance
Description
Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
Time Frame
Day 1
Title
Visual Acuity (high contrast) at near
Description
Visual Acuity (high contrast) (logMAR) at near (0.4m)
Time Frame
Day 1
Title
Visual Acuity (low contrast) at distance
Description
Visual Acuity (low contrast) at distance 6m
Time Frame
Day 1
Title
Visual Acuity (low contrast) at intermediate distance
Description
Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
Time Frame
Day 1
Title
Visual Acuity (low contrast) at near
Description
Visual Acuity (low contrast) (logMAR) at near (0.4m)
Time Frame
Day 1
Title
Overall subjective rating of lens performance in real world tasks
Description
Participants rate overall satisfaction with vision with the contact lenses on a scale of 0-100, where 0=completely dissatisfied and 100=completely satisfied, after completing a series of real world tasks.
Time Frame
Day 1
Title
Ocular aberrometry
Description
Ocular aberrometry as measured by a LADARWave aberrometer
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is at least 42 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Has previous experience with wearing MF CLs; Is able to be successfully fitted with all study lenses; Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes; Has a spectacle cylinder ≤0.75D in both eyes; Requires a reading addition of ≥+1.00D; Exclusion Criteria: A person will be excluded from the study if he/she: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment; Is aphakic; Has undergone refractive error surgery; Has monocular best-corrected VA of worse than 20/30 in each eye; Has amblyopia or strabismus; Has anisometropia >2D between both eyes For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD
Organizational Affiliation
CCLR, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population

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