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

NCT ID: NCT03538002

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2021-11-30

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional anti-reflection coated spectacle lens

Single vision lenses with correction of distant refraction and conventional anti-reflection coating

Group Type: NO_INTERVENTION

No interventions assigned to this group

Blue-light filtering spectacle lenses

Single vision lenses with correction of distant refraction and blue-light filtering coating

Group Type: EXPERIMENTAL

Blue-light filtering spectacle lenses

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ka Man Chun, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Myopia Research, The Hong Kong Polytechnic University

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

05161146

Identifier Type: -

Identifier Source: org_study_id