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OpenTrials
Completed

NCT Number: NCT02228109

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

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.

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Key information

Age range

42 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Acuvue Oasys for Presbyopia

Device

Acuvue Oasys for Presbyopia contact lenses worn

PureVision2 for Presbyopia

Device

PureVision2 for Presbyopia contact lenses worn

Biofinity Multifocal

Device

Biofinity Multifocal contact lenses worn

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Johnson & Johnson Vision Care

Registry information

Acronym: BUICK

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2014
Registry last updated
May 29, 2015

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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