MyopiaCLAMNCT02180347
Contact Lenses and Myopia
An observational study of Myopia, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Contact lenses
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2016
- Phase
- Observational
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population includes children and teens that are recruited from the University Eye Center at SUNY College of Optometry and from the greater New York City area.
Who may be able to join
- 7 to 15 years of age
- Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism
- Corrected visual acuity of 20/25 or better in each eye
Who cannot join
- Ocular or systemic disease known to affect accommodation or vision
- Convergence or accommodative disorder, or any strabismus
- Use of oral or topical medications known to affect accommodation
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY College of Optometry, Clinical Vision Research Center
New York, New York, 10036
About this study
The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.
- Conditions
- Myopia
- Being tested
- Contact lenses
- Keywords
- Pediatrics, Contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lensesDevice
| Study group | Role | What they receive |
|---|---|---|
| Multifocal contact lenses | Coopervision Proclear Multifocal Receives: Device: Contact lenses | |
| Single vision contact lenses | Coopervision Proclear Sphere Receives: Device: Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative response
Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction.
Measured: Up to two hours
Binocular posture status
Binocular posture will be measured using Modified Thorington,
Measured: Up to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Richdale, State University of New York College of Optometry
- Investigators
- Kathryn Richdale, OD, PhD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180347
- Sponsor's protocol ID
- CLAM_602929
- Other IDs
- CLAM_602929
- Acronym
- CLAM
- Status last verified
- Jul 2016
- First submitted
- 30 Jun 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lenses and Myopia
- ClinicalTrials.gov ID
- NCT02180347
- Acronym / sponsor ID
- CLAM / CLAM_602929
- Conditions
- Myopia
- Keywords
- Pediatrics, Contact lenses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jul 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 objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal contact lenses | – | Device: Contact lensesCoopervision Proclear Multifocal |
| Single vision contact lenses | – | Device: Contact lensesCoopervision Proclear Sphere |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population includes children and teens that are recruited from the University Eye Center at SUNY College of Optometry and from the greater New York City area.
Key inclusion criteria (3 listed)
- 7 to 15 years of age
- Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism
- Corrected visual acuity of 20/25 or better in each eye
Key exclusion criteria (3 listed)
- Ocular or systemic disease known to affect accommodation or vision
- Convergence or accommodative disorder, or any strabismus
- Use of oral or topical medications known to affect accommodation
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 |
|---|---|---|
| Contact lenses | Device | Multifocal contact lenses, Single vision contact lenses |
Primary outcome
Accommodative response
Time frame: Up to two hours
Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction.
Binocular posture status
Time frame: Up to two hours
Binocular posture will be measured using Modified Thorington,
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 12 Jul 2016.
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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.
Kathryn Richdale, OD, PhD principal investigator
State University of New York College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by State University of New York College of Optometry at 1 site in United States.
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 3 inclusion and 3 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 12 Jul 2016. 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 United States. 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?
Accommodative response (time frame: Up to two hours). The study lists 2 primary outcomes in all. 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 12 Jul 2016.