Control of myopia progression has become an important goal because of concerns regarding
significantly increased risks of retinal degeneration, retinal detachment, glaucoma and
cataract associated with high myopia. It is also clear there prevalence of myopia in children
and young adults is increasing all over the world. Several methods including use of
progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications
(increased outdoor activity) have reported to alter myopia progression with varying efficacy.
In general they have yielded clinical results of marginal significance. Atropine sulphate eye
drops has consistently been demonstrated to inhibit axial myopia progression in both humans
and animal models. Yet it has not found widespread clinical application for myopia control
due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has
been shown to be effective in arresting myopia progression without side-effects of
cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity.
Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy
(concentration and dosing) and safety need to be established in the population of interest,
before routine use can be recommended. We plan to evaluate the efficacy and safety of topical
0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in
Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups.
Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase
1). Control group will not receive any medications. Follow up visits will be scheduled every
three months in Phase 1. Subsequently, medication will be stopped and the study patients will
be followed up every six months for one year (Phase 2). The progression of myopia (change in
refractive error and axial length) will be compared in the two groups by objective methods.