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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Acuvue Oasys for Presbyopia; Device: PureVision2 for Presbyopia; Device: Biofinity Multifocal

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acuvue Oasys for Presbyopia; Acuvue Oasys for Presbyopia contact lenses worn	Device: Acuvue Oasys for Presbyopia; Acuvue Oasys for Presbyopia contact lenses worn
Experimental: PureVision2 for Presbyopia; PureVision2 for Presbyopia contact lenses worn	Device: PureVision2 for Presbyopia; PureVision2 for Presbyopia contact lenses worn
Experimental: Biofinity Multifocal; Biofinity Multifocal contact lenses worn	Device: Biofinity Multifocal; Biofinity Multifocal contact lenses worn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity (high contrast) at distance	Visual Acuity (high contrast) (logMAR) at distance 6m	Day 1
Visual Acuity (high contrast) at intermediate distance	Visual Acuity (high contrast) (logMAR) at intermediate distance 1m	Day 1
Visual Acuity (high contrast) at near	Visual Acuity (high contrast) (logMAR) at near (0.4m)	Day 1
Visual Acuity (low contrast) at distance	Visual Acuity (low contrast) at distance 6m	Day 1
Visual Acuity (low contrast) at intermediate distance	Visual Acuity (low contrast) (logMAR) at intermediate distance 1m	Day 1
Visual Acuity (low contrast) at near	Visual Acuity (low contrast) (logMAR) at near (0.4m)	Day 1
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.	Day 1
Ocular aberrometry	Ocular aberrometry as measured by a LADARWave aberrometer	Day 1

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Johnson & Johnson Vision Care
• Investigators: Principal Investigator: Lyndon Jones, PhD, CCLR, University of Waterloo

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 20067