Two ophthalmic technicians with prior experience of 5
and 3 years and one ophthalmologist with prior experience of 4 years
performed all examination procedures in a clinic set up at the rural
eye center specifically for the study. Examinations were generally
performed during standard clinic hours and 6 days a week. Examination
procedures have been described in detail elsewhere.
5
In brief, the examination by the ophthalmic technicians included
distance visual acuity measurements, ocular motility evaluation, and
retinoscopy and autorefraction after cycloplegia, as well as subjective
refraction in those with uncorrected visual acuity of 20/40 or worse in
either eye. Visual acuity was measured at 4 m, using a
retroilluminated log minimum angle of resolution (MAR) chart with five
E optotypes on each line (Precision Vision, La Salle, IL), and recorded
as the smallest line read with one or no errors. The right eye was
tested first and then the left, both with (presenting visual acuity)
and without glasses (uncorrected visual acuity), if the child brought
them. Lens power was measured with a lensometer. Ocular motility was
evaluated at both 0.5 and 4.0 m. Tropias were categorized as
esotropia, exotropia, or vertical, with the degree of tropia measured
using the corneal light reflex. Pupils in each eye were dilated with 2
drops of 1% cyclopentolate with an interval of 5 minutes. After 20
minutes, if pupillary light reflex was still present, a third drop was
administered. Light reflex and pupil dilation were evaluated after an
additional 15 minutes. Cycloplegia was considered complete if the pupil
was dilated to 6 mm or more and light reflex was absent. Refraction was
performed in children after cycloplegic refraction, regardless of their
visual acuity, using streak retinoscopy. Cycloplegic autorefraction was
performed using a handheld autorefractor (Retinomax K-Plus; Nikon
Corp., Tokyo, Japan), with calibration at the beginning of each day.
Subjective refraction was performed in children with uncorrected visual
acuity of 20/40 or worse in either eye.
The study ophthalmologist evaluated the anterior segment using a slit
lamp and the media and fundus using a slit lamp and indirect
ophthalmoscope. The principal cause of visual impairment of 20/40 or
worse was assigned after completion of the ocular examination, using a
seven-item list (refractive error, amblyopia, corneal opacity due to
trachoma, other corneal opacity, cataract, retinal disorder, other
causes). Refractive error was recorded as the cause of visual
impairment in eyes improving to 20/32 or better with refractive
correction. Amblyopia was considered the cause of impairment in eyes
with best corrected visual acuity of 20/40 or worse and no apparent
organic lesion, so long as one or more of the following criteria were
met: (1) esotropia, exotropia, or vertical tropia at 4-m fixation or
exotropia or vertical tropia at 0.5 m; (2) anisometropia of 2.00
spherical equivalent diopters or more; and (3) bilateral ametropia of
at least +6.00 spherical equivalent diopters.
Children whose vision improved with refractive error correction in
either eye were prescribed and provided spectacles within 2 weeks of
the examination. Children needing medical or surgical treatment were
referred to the rural eye center for treatment.
Survey fieldwork was preceded by a pilot study in three nonstudy
clusters in the district in February and March 2000. For 2 weeks before
the pilot, the study team was trained in RESC procedures. Retraining
was performed for visual acuity assessment and other procedures found
to be difficult in younger children during the pilot study.
Reproducibility of visual acuity measurements, objective refraction,
and autorefraction was assessed between the two ophthalmic technicians
during the pilot.
The survey was approved by the Ethics Committee of the L. V.
Prasad Eye Institute, Hyderabad, India. Human subject research approval
for the study protocol was obtained from the World Health Organization
Secretariat Committee on Research Involving Human Subjects. The
research protocol adhered to the provisions of the Declaration of
Helsinki for research involving human subjects.