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

January 12, 2022 updated by: The Hong Kong Polytechnic University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic refraction
Time Frame: 2 years
Refraction done under cycloplegia
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 2 years
Length of eyeball that is directly related to myopia
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05161146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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