Screening device accurately detects amblyopia (lazy eye)
Early detection is key to treating condition that can affect children's success in school and lifelong visual acuity

Date:
September 27, 2021
Source:
NIH/National Eye Institute
Summary:
A handheld screening device that detects subtle misalignment of
the eyes accurately identifies children with amblyopia (lazy eye),
according to a new study.



FULL STORY ==========================================================================
A handheld screening device that detects subtle misalignment of the eyes accurately identifies children with amblyopia (lazy eye), according to a
study published in the Journal of the American Association for Pediatric Ophthalmology and Strabismus.


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"The findings suggest that pediatricians and other primary care providers
could use the device to catch amblyopia at an early age when it's easier
to treat," said Michael F. Chiang, M.D., director of the National
Eye Institute (NEI), which supported research and development of the
device. NEI is part of the National Institutes of Health.

Amblyopia is impaired vision in one eye and it is the leading cause of preventable monocular (single eye) vision loss, affecting three of every
100 children in the U.S.

During early childhood, our developing brains learn how to take
images from each eye and fuse them into a single image to produce
vision. Amblyopia develops when misalignment of the eyes (strabismus)
or decreased acuity in one eye interferes with the brain's ability to
process visual information from both eyes, causing it to favor one
eye. Once a child is visually mature, vision lost in the weaker eye
cannot be corrected with glasses or contact lenses.

Children with amblyopia can suffer from poor school performance and
impairments in depth perception and fine motor skills such as handwriting
and other hand- eye coordinated activities.

Treatment of amblyopia generally involves placing a patch over the good
eye to improve vision in the weaker eye. Patching is less successful as children get older, making early detection crucial. However, this depends
on timely diagnosis by the child's doctor, and most pediatricians are
equipped only for basic eye chart vision screening tests, which are not
useful for detecting amblyopia in very young children.



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The screening device works by assessing the eyes' ability to fixate
together.

Held 14 inches from the eyes, the child fixates on a smiley face while the device simultaneously scans both retinas. The scan involves a polarized
laser that probes nerve fibers in an area of the light-sensing retina
called the fovea, which is important for central vision. Even a subtle misalignment of the foveas -- called small-angle strabismus -- can
interfere with the brain's ability to integrate images from both eyes. The device calculates a binocularity score that indicates whether the child requires referral to an eye health physician for further investigation.

For the study, 300 children, ages 2 to 6 years, with no known eye
disorders were recruited during previously scheduled visits to two Kaiser Permanente Southern California pediatric clinics.

Two non-ophthalmic research associates who were trained how to use the
device screened each child, and the results were compared against those
from an eye examination performed by a pediatric ophthalmologist who was unaware of the device's results. The device detected all six cases (100% sensitivity) of amblyopia and/or strabismus that had been confirmed by
the professional eye examination. The device also flagged an additional
45 children as possibly having amblyopia and/or strabismus who were
later determined by the eye examination to be normal (85% specificity).

"In the hands of a trained user, it takes 28 seconds to sit the child
down, perform the test, and record the results -- provided that the child cooperates -- which is an important consideration for its adoption in
busy pediatric care settings," said the study's co-lead investigator,
Shaival S. Shah, M.D., a pediatric ophthalmologist at Kaiser Permanente
based in Tustin Ranch, California. The test itself requires just 2.5
seconds of a child's attention.

A key limitation of the study was that the device was not compared
with currently available photo-screening devices. Such devices detect differences in light reflexes in each eye and produce images that can
help detect risk factors for amblyopia, but not amblyopia itself, which
can result in both over and under detection of amblyopia.

By contrast, the pediatric vision scanner detects the presence of
amblyopia as opposed to the risk factors of amblyopia, which may lead
to fewer unnecessary referrals to pediatric ophthalmologists.

The pediatric vision screener tested in the study is a prototype
of blinq. (R), a device that was cleared by the U.S. Food and Drug Administration in 2016.

The clinical trial identifier is NCT02536963. The study was supported
by NEI grant R44EY025926 to Rebiscan, Inc. (doing business as Rebion),
the Boston- based firm that markets blinq.(R). Support was provided
under the Small Business Innovation Research (SBIR) program, a funding mechanism that helps independently owned companies with 500 or fewer
employees bring biomedical technologies to the market.

Co-founder of Rebion, David Hunter, M.D., Ph.D., ophthalmologist-in-chief
at Boston Children's Hospital, co-invented blinq.(R) with support from
NEI grant R01EY012883.

========================================================================== Story Source: Materials provided by NIH/National_Eye_Institute. Note:
Content may be edited for style and length.


========================================================================== Journal Reference:
1. Shah SS, Jimenez JJ, Rozema EJ, Nguyen MT, Preciado M, and Mehta AM.

Validation of the Pediatric Vision Scanner in a normal preschool
population. J AAPOS, 2021 DOI: 10.1016/j.jaapos.2021.03.010 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/09/210927172906.htm

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