Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

Myopia Clinical Trial

Official title: A Double-masked, Randomized, Cross-over Comparative Study of Novel Myopia Control Designed Lens (Test Lens) Versus Single Vision Lens (SVL; Control)

Status Active, not recruiting

Clinical Trial Summary

This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.

Clinical Trial Description

Myopia has been considered as a 'global epidemic' owing to its rapid rise in prevalence across the world. Myopia significantly affects the quality of life of an individual socially by restriction of employment in various fields and economically by additional cost for eye care and spectacles and contact lenses (Lim, Gazzard et al. 2009). In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which can could lead to blindness. Several optical and pharmaceutical strategies were developed over the recent years that could control or slow the progression of myopia.

It has been shown that persistent myopic defocus constantly applied on the whole retina has a beneficial effect on myopia progression, i.e. decrease in myopia progression (Anstice and Phillips 2011, Cheng, Woo et al. 2011, Ehsaei, Chisholm et al. 2011). In addition, a meta-analysis on the efficacy of non-invasive optical treatment strategies for myopia control reported prismatic bifocals to have the best outcome (Cheng, Woo et al. 2011). Therefore, test lenses were designed to increase the area and amount of myopic defocus on the retina without compromising vision.

Thus, this study aims to evaluate the efficacy of test lenses to reduce the progression of myopia by either reducing the myopia progression rate per year and/or reducing the elongation of eyeball through myopic defocus compared with SVL. A total of 120 healthy children aged 8 to 13 years will be recruited to participate in a double-masked cross-over clinical trial. Cycloplegic autorefraction will be the primary measure for myopia progression and axial length will the secondary outcome measure. Visual acuity will also be compared between test lens and control lens to determine the quality of vision using test lens. ;

Related Conditions & MeSH terms

• Myopia

• NCT number: NCT04048148
• Study type: Interventional
• Source: Brien Holden Vision Institute
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2019
• Completion date: May 31, 2021