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

Myopia Clinical Trial

Official title:

Does Blue-light Filtering Spectacle Lens Promote Myopia Progression in Schoolchildren

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538002
• Other study ID #: 05161146
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Blue-light filtering spectacle lenses
This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.

Locations

Country	Name	City	State
Hong Kong	Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic refraction	Refraction done under cycloplegia	2 years
Secondary	Axial length	Length of eyeball that is directly related to myopia	2 years