The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Blue-light filtering spectacle lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring blue light filtering spectacle lens
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.
Sites / Locations
- Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional anti-reflection coated spectacle lens
Blue-light filtering spectacle lenses
Arm Description
Single vision lenses with correction of distant refraction and conventional anti-reflection coating
Single vision lenses with correction of distant refraction and blue-light filtering coating
Outcomes
Primary Outcome Measures
Cycloplegic refraction
Refraction done under cycloplegia
Secondary Outcome Measures
Axial length
Length of eyeball that is directly related to myopia
Full Information
NCT ID
NCT03538002
First Posted
May 15, 2018
Last Updated
January 12, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03538002
Brief Title
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
Official Title
Does Blue-light Filtering Spectacle Lens Promote Myopia Progression in Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
blue light filtering spectacle lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional anti-reflection coated spectacle lens
Arm Type
No Intervention
Arm Description
Single vision lenses with correction of distant refraction and conventional anti-reflection coating
Arm Title
Blue-light filtering spectacle lenses
Arm Type
Experimental
Arm Description
Single vision lenses with correction of distant refraction and blue-light filtering coating
Intervention Type
Device
Intervention Name(s)
Blue-light filtering spectacle lenses
Intervention Description
This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.
Primary Outcome Measure Information:
Title
Cycloplegic refraction
Description
Refraction done under cycloplegia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Axial length
Description
Length of eyeball that is directly related to myopia
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Man Chun, PhD
Organizational Affiliation
Centre for Myopia Research, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
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