The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Blue-light filtering spectacle lenses

• Registration Number: NCT03538002
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.

Detailed Description

The effect of blue light on ocular health has been studied extensively. Shorter wavelength such as blue light could cause damage to the retina. The damage was more evident in the ageing eye. Since the tablets and mobile with blue LED backlight display are widely used, thus blue-light filtering spectacle lenses are now available in the market. However, whether this kind of lenses could affect the eye growth in schoolchildren is unknown. This study is then designed to investigate if the blue-light filtering spectacle lenses affect myopia progression in Hong Kong Chinese schoolchildren. The schoolchildren will be randomly allocated to either blue-light filtering spectacle lens group (treated) or conventional spectacle lens group (control). Their axial length and refraction will be monitored every 6 months for 2 years. The changes between two group will then be compared.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-25
• Study Start: 2018-09-10
• Status Verified: 2021-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Refraction: myopia of -1.00 dioptres (D) to -5.00D
• Astigmatism: equal or less than -1.50D
• Anisometropia: equal or less than 1.00D
• Best corrected monocular visual acuity: 0.0 LogMAR or better after full correction
• Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria

• any ocular and systemic abnormalities might affect visual functions or refractive development
• prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue-light filtering spectacle lenses	Blue-light filtering spectacle lenses	Single vision lenses with correction of distant refraction and blue-light filtering coating

Primary Outcome Measures

Name	Time	Method
Cycloplegic refraction	2 years	Refraction done under cycloplegia

Secondary Outcome Measures

Name	Time	Method
Axial length	2 years	Length of eyeball that is directly related to myopia

Trial Locations

Locations (1)

Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong