First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age

Uncorrected refractive error is a frequent cause of visual impairment in children most
prevalent in rural or underserved areas in the global population. In 2006, the World Health
Organization released global estimates on visual impairment. According to their findings,
there are approximately 314 million people in the world whose vision is impaired. Of this
population 90% of those individuals live in developing countries and 153 million cases are
believed to be due to uncorrected refractive error. Children, ages five to 15 years, suffer
from refractive errors (mostly myopia, hyperopia, and astigmatism) that can be improved to
normal vision. It is estimated that by 2020, approximately one third of the world's
population (2.5 billion) will be affected by myopia alone14. The prevalence of refractive
error in school-aged children is significant especially the impact on a child's life in
terms of education and development.

Studies in Western populations have collectively shown that myopia occurs <5% in children 8
years and younger. Sampling studies in other countries worldwide have shown that there is
higher prevalence of myopia among Southeast Asia children and less among Australian
children.1-11 Refractive error study in Eastern Nepal found 2.9% of children had vision of
20/40 or worse of which 56% of the 200 eyes tested was caused by refractive error due to
myopia, hyperopia and astigmatism.12

The challenge is to determine the most effective and accessible method of detecting
refractive error and dispensing spectacles for better vision. Children who have access to
clinical setting typically receive prescriptive spectacles to correct refractive errors.
However, in underserved areas where standard eye care may be absent, children are unable to
receive the benefits of normal or near normal vision. The challenge is to determine the most
effective and accessible method of detecting refractive error and dispensing spectacles for
better vision

In the clinical setting, refractive error is corrected by prescribing spectacles or contact
lenses on a daily basis. Typically the patient will first undergo autorefraction, in which a
computer-controlled machine objectively calculates the refractive error present as a
starting point for the subjective refraction test. This machine, however, is cumbersome and
not easily transportable abroad. Typically the machine is held up to the patient's forehead
and they are asked to look into the machine at a distant object. While they are looking at
this object the machine calculates the refractive error.

First-Sight is a simplified way to correct refractive error. It is easily portable, making
it accessible to remote areas of the world. Unlike the study cited above, First-Sight can be
taken to remote areas where clinics are not available and patients are not able to afford to
pay for the clinic visit. As it is a simplified technique, local health care workers may
easily be able to learn how to use First-Sight and dispense spectacles to those in need.
Lastly, sponsors of First-Sight will provide the refracting kit and dispense custom-made
spectacles at no cost to health care workers and children respectively.

Inclusion Criteria:

1. Subjects are between 7 to 18 years of age.

2. Healthy subjects

3. A refractive error of -4.50 to +4.50 diopter spherical error and astigmatism up to
-1.50 diopters on manifest refraction and autorefraction as documented in their
medical records.

4. Best corrected visual acuity (BCVA) of 20/20 with cycloplegic refraction.

5. No known ocular pathology from previous clinical exams that may limit best corrected
visual acuity.

Exclusion Criteria:

1. Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than
-1.50 diopters.

2. Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit
BCVA.

3. Best corrected visual acuity with spectacles of 20/25 or worse.

4. Any previous surgical or laser procedures that may limit BCVA

5. Narrow angles of the eyes

6. Adults, 19 years or older