Status:
COMPLETED
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Johnson & Johnson Vision Care
Conditions:
Presbyopia
Eligibility:
All Genders
42+ years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02228109
Start Date
December 1 2014
End Date
April 1 2015
Last Update
May 29 2015
Active Locations (1)
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1
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1