Enhancement of Emmetropization in Highly Hyperopic Infants



Status:Not yet recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:3/15/2019
Start Date:April 1, 2019
End Date:December 2020
Contact:Ann M Morrison, OD, MS
Email:morrison.421@osu.edu
Phone:614-247-0010

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The Enhancement Via Accommodation (EVA) Study

Infants do not usually wear glasses because they usually do not need them to see clearly.
Most infants are born with a moderate amount of farsightedness. Most infants then undergo a
natural process called 'emmetropization' that reduces the amount of farsightedness. However,
up to 10% of infants don't emmetropize and end up with very farsighted prescriptions.
Farsighted infants must use extra focusing effort to see clearly, which may make their eyes
cross and perhaps cause a "lazy eye". If infants avoid this effort and their vision stays
blurred into childhood, they may develop two lazy eyes. Farsightedness in school-aged
children makes reading and learning more difficult. New studies in animals and in humans show
that infant eyes will emmetropize best if they have just a normal, moderate amount of
farsightedness. The infant eye must be in this normal target zone in order to emmetropize. If
a baby were given glasses with the full prescription to correct all of his farsightedness,
the eyes would also be out of the target zone and would not receive any signal to grow. The
best strategy might be to give a partial spectacle correction for the farsightedness, just
enough to put them in the zone that is most effective for emmetropization.

The purpose of this project is to determine if emmetropization can be enhanced in very
farsighted babies. We will give them glasses with a partial correction and accommodative (eye
focusing) training. The partial correction is an amount that is less than their full degree
of farsightedness but enough to put them in the zone of effective emmetropization. As changes
in farsightedness occur, the power of the glasses will be reduced to keep the farsightedness
within the target zone. If an infant reaches a normal amount of farsightedness, the glasses
will be discontinued. The comparison group will be farsighted babies who receive the current
standard of care, namely no correction. The main outcome of the study will be whether there
is a significant difference in the decrease of farsightedness between the two groups when the
infants are 18 months of age.

If emmetropization can be enhanced in very farsighted babies, the risk of developing crossed
or lazy eye will be reduced. The lifelong need for spectacles, contact lenses, or refractive
surgery for high amounts of farsightedness would also be reduced. Positive results might also
make infant eye examinations more common and place a new therapeutic option in clinicians'
hands.


Inclusion Criteria:

- Age: between 8 and 20 weeks at baseline examination

- Either gender

- Any ethnicity

- Birthweight greater than 2500g

- Normal pregnancy and delivery (including Cesarean section delivery but excluding
serious complications or conditions such as eclampsia or rubella)

- Hyperopia greater than or equal to +5.00 Diopters(D) spherical equivalent refractive
error in each eye measured with the Welch Allyn SureSight using 1% cyclopentolate

- Infants with a refractive error of greater than or equal to +5.00D to less than or
equal to +7.00D will be randomized to treatment (partial correction with accommodative
training) or observation only.

- Infants with a refractive error greater than +7.00D will receive treatment

Exclusion Criteria:

- Astigmatism greater than 2.00D in either eye

- Anisometropia greater than 1.00D (spherical equivalent)

- History of strabismus surgery

- History of difficulty with pupillary dilation

- History of cardiac, liver, asthma, or other respiratory disease

- History of ocular disease, retinal detachment, severe macular dragging, intraocular
surgery, optic nerve hypoplasia, malformations of the eye, cortical visual impairment
or active inflammation

- History of hydrocephalus, Down syndrome, cerebral palsy, developmental delay, seizure
disorders
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-247-0010
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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mi
from
Columbus, OH
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