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

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ClinicalTrials.gov Identifier: NCT02228109
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
Johnson & Johnson Vision Care
Information provided by (Responsible Party):
University of Waterloo

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Acuvue Oasys for Presbyopia Device: PureVision2 for Presbyopia Device: Biofinity Multifocal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  1. Decentration [ Time Frame: Day 1 ]
    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 :
  1. Visual Acuity (high contrast) at distance [ Time Frame: Day 1 ]
    Visual Acuity (high contrast) (logMAR) at distance 6m

  2. Visual Acuity (high contrast) at intermediate distance [ Time Frame: Day 1 ]
    Visual Acuity (high contrast) (logMAR) at intermediate distance 1m

  3. Visual Acuity (high contrast) at near [ Time Frame: Day 1 ]
    Visual Acuity (high contrast) (logMAR) at near (0.4m)

  4. Visual Acuity (low contrast) at distance [ Time Frame: Day 1 ]
    Visual Acuity (low contrast) at distance 6m

  5. Visual Acuity (low contrast) at intermediate distance [ Time Frame: Day 1 ]
    Visual Acuity (low contrast) (logMAR) at intermediate distance 1m

  6. Visual Acuity (low contrast) at near [ Time Frame: Day 1 ]
    Visual Acuity (low contrast) (logMAR) at near (0.4m)

  7. Overall subjective rating of lens performance in real world tasks [ Time Frame: Day 1 ]
    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.

  8. Ocular aberrometry [ Time Frame: Day 1 ]
    Ocular aberrometry as measured by a LADARWave aberrometer



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Ages Eligible for Study:   42 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228109


Locations
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Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Johnson & Johnson Vision Care
Investigators
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Principal Investigator: Lyndon Jones, PhD CCLR, University of Waterloo

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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT02228109     History of Changes
Other Study ID Numbers: 20067
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases