PresbyopiaBUICKNCT02228109
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population
A study testing Acuvue Oasys for Presbyopia, PureVision2 for Presbyopia and Biofinity Multifocal in people with Presbyopia, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Acuvue Oasys for Presbyopia, PureVision2 for Presbyopia and Biofinity Multifocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
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
- Being tested
- Acuvue Oasys for Presbyopia, PureVision2 for Presbyopia, Biofinity Multifocal
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue Oasys for PresbyopiaDevice
Acuvue Oasys for Presbyopia contact lenses worn
PureVision2 for PresbyopiaDevice
PureVision2 for Presbyopia contact lenses worn
Biofinity MultifocalDevice
Biofinity Multifocal contact lenses worn
| Study group | Role | What they receive |
|---|---|---|
| Acuvue Oasys for Presbyopia | Experimental | Acuvue Oasys for Presbyopia contact lenses worn Receives: Device: Acuvue Oasys for Presbyopia |
| PureVision2 for Presbyopia | Experimental | PureVision2 for Presbyopia contact lenses worn Receives: Device: PureVision2 for Presbyopia |
| Biofinity Multifocal | Experimental | Biofinity Multifocal contact lenses worn Receives: Device: Biofinity Multifocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (8)
Visual Acuity (high contrast) at distance
Visual Acuity (high contrast) (logMAR) at distance 6m
Measured: Day 1
Visual Acuity (high contrast) at intermediate distance
Visual Acuity (high contrast) (logMAR) at intermediate distance 1m
Measured: Day 1
Visual Acuity (high contrast) at near
Visual Acuity (high contrast) (logMAR) at near (0.4m)
Measured: Day 1
Visual Acuity (low contrast) at distance
Visual Acuity (low contrast) at distance 6m
Measured: Day 1
Visual Acuity (low contrast) at intermediate distance
Visual Acuity (low contrast) (logMAR) at intermediate distance 1m
Measured: Day 1
Visual Acuity (low contrast) at near
Visual Acuity (low contrast) (logMAR) at near (0.4m)
Measured: 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.
Measured: Day 1
Ocular aberrometry
Ocular aberrometry as measured by a LADARWave aberrometer
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, Principal investigator, CCLR, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228109
- Sponsor's protocol ID
- 20067
- Acronym
- BUICK
- Status last verified
- May 2015
- First submitted
- 26 Aug 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population
- ClinicalTrials.gov ID
- NCT02228109
- Acronym / sponsor ID
- BUICK / 20067
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acuvue Oasys for Presbyopia | Experimental | Device: Acuvue Oasys for PresbyopiaAcuvue Oasys for Presbyopia contact lenses worn |
| PureVision2 for Presbyopia | Experimental | Device: PureVision2 for PresbyopiaPureVision2 for Presbyopia contact lenses worn |
| Biofinity Multifocal | Experimental | Device: Biofinity MultifocalBiofinity Multifocal contact lenses worn |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuvue Oasys for PresbyopiaAcuvue Oasys for Presbyopia contact lenses worn | Device | Acuvue Oasys for Presbyopia |
| PureVision2 for PresbyopiaPureVision2 for Presbyopia contact lenses worn | Device | PureVision2 for Presbyopia |
| Biofinity MultifocalBiofinity Multifocal contact lenses worn | Device | Biofinity Multifocal |
Primary outcome
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.
8 secondary outcomes
Visual Acuity (high contrast) at distance
Time frame: Day 1
Visual Acuity (high contrast) at intermediate distance
Time frame: Day 1
Visual Acuity (high contrast) at near
Time frame: Day 1
Visual Acuity (low contrast) at distance
Time frame: Day 1
Visual Acuity (low contrast) at intermediate distance
Time frame: Day 1
Visual Acuity (low contrast) at near
Time frame: Day 1
Overall subjective rating of lens performance in real world tasks
Time frame: Day 1
Ocular aberrometry
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD principal investigator
CCLR, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue Oasys for Presbyopia, PureVision2 for Presbyopia and Biofinity Multifocal in people with Presbyopia, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decentration (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.