How many children will participate in this study?
A total of 294 children are expected to participate. There are two clinical centers-- The Ohio State University College of Optometry and the University of Houston College of Optometry. Each clinic site is expected to enroll approximately 147 children.
When did this study start and how long will you be enrolling subjects?
The first study subjects were enrolled in September 2014 and recruitment is ongoing. Please contact your local clinic site for more information.
What kind of contact lenses are being used in the study?
The three types of contact lenses we are using in the study are all FDA-approved soft contact lenses. All contact lenses are disposable lenses that are thrown away at the end of each month. The contact lenses are worn during the day and are removed each night. The brand name is Biofinity, and we are using a spherical lens (“regular contact lens”) as well as two bifocal contact lenses with different reading powers (+1.50 and +2.50). The use of the bifocal lenses to try to slow the progression of nearsightedness (myopia) is considered investigational in this study, as these lenses would normally be worn by people over the age of 40 who have trouble seeing up close.
How long will my child wear each type of lens?
Children are randomly assigned to wear one of the three lens types and would wear the same lens for at least the three-year study period. This is a "masked" study, meaning you will not be told which of the lenses your child receives.
How well do children see with these contact lenses?
As with any contact lens prescription, no child is dispensed lenses unless his or her vision is acceptable at distance and for reading. Our preliminary studies show that children see as well with these lenses as with any other soft lens on the market.
How old must my child be to participate in the BLINK Study?
Children must be at least 7 years old but not older than 11 years when they are seen for their first visit.
My child just turned 12, can he/she be in the study?
No, only children 7-11 years old can be enrolled in the study. If your child is already 12, he/she is no longer eligible for the BLINK Study.
If my child chooses frames that exceed the frame allowance, can I use my insurance benefits for the balance of the costs?
Unfortunately, this is not possible. Any costs that exceed the frame allowance will need to be paid at your expense. You should be able to use a health savings account/flexible spending account, if applicable, to pay these out of pocket expenses.
Is this research being monitored by someone?
This study is approved by the Ohio State University Biomedical Sciences Institutional Review Board and the University of Houston Committee for the Protection of Human Subjects, which protect human subjects who participate in research at The Ohio State University and the University of Houston. BLINK safety issues and results are also monitored by a Data Safety and Monitoring Committee appointed by the National Eye Institute.
Is someone paying you to conduct this study?
This study is sponsored by the National Eye Institute, a division of the National Institutes of Health.
Have other studies been conducted with kids wearing bifocal contact lenses?
Yes, other studies have been conducted. Previous studies have found that soft bifocal contact lenses may slow the progression of nearsightedness and growth of the eye. However, each study used different contact lens designs, none of the studies lasted more than two years, and only one study was a randomized clinical trial. In order to determine whether these commercially available lenses actually slow the progression of nearsightedness and learn how they may slow eye growth, we must conduct a long-term randomized clinical trial. This is the rationale behind the BLINK Study.
What are the risks associated with my child wearing these contact lenses?
The risks of contact lens wear in the BLINK Study are the same as if your child were to be fitted with contact lenses by a doctor outside of the study. Proper contact lens care is the best way to ensure success as a contact lens wearer and to avoid contact lens-related problems. Young kids are amazingly capable of caring for their own contact lenses. Our study doctors will work with your child to ensure that he/she understands how to properly care for his/her contact lenses. Our study doctors are happy to answer any questions you may have about contact lens wear.
I was previously told that my child has astigmatism. Can children with astigmatism participate in the study?
We can accept certain amounts of astigmatism, but we will need you to call us with your child’s glasses prescription so we can better determine if your child might be eligible.
Are there conditions that would exclude my child from participating in the study?
Children with certain eye conditions such as strabismus (an eye turn) or amblyopia (a lazy eye) are excluded from participating in the study. Additionally, children with diabetes and certain syndromes are excluded. The clinic coordinator will review this with you when you call.
Will I receive the results of the study?
This study is registered at ClinicalTrials.gov, a website intended to link patients to medical research. Information about the study is already posted on this site, and once the study is completed the results will be posted there as well. Study information at ClinicalTrials.gov can be found here.
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