A Two-year, Randomized, Single-centre, Double-masked, Comparative Study to Evaluate the Annual Rate of Myopia Progression of Children With Myopia Receiving Daily BHVI1, BHVI2 Eye Drops Either Alone or in Combination

Detailed Summary

Myopia currently affects 30% of the world and by 2050, almost 50% of the world will be myopic based on conservative estimates.1 In 2050, this will equate to almost 5 billion people with myopia, and those with high myopia will total almost 1 billion.1 Due to the growing public health concerns surrounding myopia, including treatments for visual complications associated with high myopia, the resultant lost productivity and increased cost to society, a solution to ameliorate this issue is imperative. Current treatment strategies cannot prevent myopia, and their ability to slow myopia progression is variable, ranging from 10% to 59%.2 Based on the meta-analysis between the different interventions for myopia control, atropine eye-drops were proved the most effective strategy.3 Atropine has been used in myopia control treatment over the last 30 years in many countries with no serious adverse events reported.4-6 Moreover, atropine, a non-selective antimuscarinic agent, has been regularly applied in multiple other ocular conditions with respect to the official FDA approvals.7 8 Regarding the myopia management, recent studies show the significant effect of low dose atropine in controlling the progression of spherical equivalent with the least side-effects such as photophobia and blurry near vision.9 However, the lack of substantial data in reducing the axial growth rate of low dose atropine proposes a need of either using higher dose of atropine or in combination with other pharmaceutical agent having such the effect. We therefore aim to determine in a two-year clinical trial, the efficacy of the eye drops used in our clinical trial for its role in slowing progression of myopia.

Study Details

Timeline

Interventions