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

NCT ID: NCT02228109

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Acuvue Oasys for Presbyopia

Acuvue Oasys for Presbyopia contact lenses worn

Group Type: EXPERIMENTAL

Acuvue Oasys for Presbyopia

Intervention Type: DEVICE

Acuvue Oasys for Presbyopia contact lenses worn

PureVision2 for Presbyopia

PureVision2 for Presbyopia contact lenses worn

Group Type: EXPERIMENTAL

PureVision2 for Presbyopia

Intervention Type: DEVICE

PureVision2 for Presbyopia contact lenses worn

Biofinity Multifocal

Biofinity Multifocal contact lenses worn

Group Type: EXPERIMENTAL

Biofinity Multifocal

Intervention Type: DEVICE

Biofinity Multifocal contact lenses worn

Interventions

Acuvue Oasys for Presbyopia

Acuvue Oasys for Presbyopia contact lenses worn

Intervention Type: DEVICE

PureVision2 for Presbyopia

PureVision2 for Presbyopia contact lenses worn

Intervention Type: DEVICE

Biofinity Multifocal

Biofinity Multifocal contact lenses worn

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care

UNKNOWN

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

CCLR, University of Waterloo

Locations

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

20067

Identifier Type: -

Identifier Source: org_study_id