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Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Myopia Clinical Trial

Official title:
Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial

Clinical Trial Summary

The aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). Myopic progression is quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months crossover) with double-masking. Peripheral refraction and ocular aberration will be evaluated.

Clinical Trial Description

Visual manipulation induced by progressive addition lenses (PALs) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. However, the treatment effect of PALs is statistically significant but clinically insufficient. The current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. This prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. It is a double-masked, cross-over study. One eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. Subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. Both the subjects and examiners will not aware the lens design being used by the subjects in each phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02700139
Study type Interventional
Source The Hong Kong Polytechnic University
Contact
Status Terminated
Phase N/A
Start date January 2016
Completion date August 2017
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