MyopiaNCT03538002
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
A study testing Blue-light filtering spectacle lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Blue-light filtering spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Sep 2018to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University
Hong Kong, 00000
About this study
Official title: 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.
Read the 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
- Being tested
- Blue-light filtering spectacle lenses
- Keywords
- blue light filtering spectacle lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue-light filtering spectacle lensesDevice
This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.
| Study group | Role | What they receive |
|---|---|---|
| Conventional anti-reflection coated spectacle lens | No intervention | Single vision lenses with correction of distant refraction and conventional anti-reflection coating |
| Blue-light filtering spectacle lenses | Experimental | Single vision lenses with correction of distant refraction and blue-light filtering coating Receives: Device: Blue-light filtering spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction
Refraction done under cycloplegia
Measured: 2 years
Secondary outcomes (1)
Axial length
Length of eyeball that is directly related to myopia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start10 Sep 2018
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Man Chun, PhD, Principal investigator, Centre for Myopia Research, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538002
- Sponsor's protocol ID
- 05161146
- Status last verified
- Jan 2021
- First submitted
- 15 May 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Blue-light Filtering Spectacle Lens Promote Myopia Progression in Schoolchildren
- ClinicalTrials.gov ID
- NCT03538002
- Acronym / sponsor ID
- 05161146
- Conditions
- Myopia
- Keywords
- blue light filtering spectacle lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional anti-reflection coated spectacle lens | No intervention | –Single vision lenses with correction of distant refraction and conventional anti-reflection coating |
| Blue-light filtering spectacle lenses | Experimental | Device: Blue-light filtering spectacle lensesSingle vision lenses with correction of distant refraction and blue-light filtering coating |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue-light filtering spectacle lensesThis is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating. | Device | Blue-light filtering spectacle lenses |
Primary outcome
Cycloplegic refraction
Time frame: 2 years
Refraction done under cycloplegia
1 secondary outcome
Axial length
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Man Chun, PhD principal investigator
Centre for Myopia Research, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue-light filtering spectacle lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic refraction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.