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

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT03538002

Collaborator

(none)

148

Enrollment

Location

Arms

38.7

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Blue-light filtering spectacle lenses	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 10, 2018

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional anti-reflection coated spectacle lens Single vision lenses with correction of distant refraction and conventional anti-reflection coating
Experimental: Blue-light filtering spectacle lenses Single vision lenses with correction of distant refraction and blue-light filtering coating	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.

Arm

Intervention/Treatment

No Intervention: Conventional anti-reflection coated spectacle lens

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

Experimental: Blue-light filtering spectacle lenses

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

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.

Outcome Measures

Primary Outcome Measures

Cycloplegic refraction [2 years]
Refraction done under cycloplegia

Secondary Outcome Measures

Axial length [2 years]
Length of eyeball that is directly related to myopia

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

Principal Investigator: Ka Man Chun, PhD, Centre for Myopia Research, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT03538002

Other Study ID Numbers:

05161146

First Posted:

May 25, 2018

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Hong Kong Polytechnic University

blue light filtering spectacle lens

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Jan 13, 2022