MyopiaNCT02150421
Impact of Electronic Devices on Myopia Development and Progression
An observational study of Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Feb 2016
- Phase
- Observational
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary schoolchildren in Hong Kong
Who may be able to join
- Chinese
- study local primary schools
Who cannot join
- with any ocular diseases and binocular anomalies might affect visual functions or refractive development
- with history of eye surgery
- have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-K, eyedrops (e.g. atropine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren
The aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function.
Read the detailed description
With the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. Parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology.
This is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren.
The schools will introduce e-books to their students in some classes. Signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. Eye examination and data collection will be conducted in primary school campus. The children from two local primary schools in same grade will be assigned into two groups by their schools. One group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). Their refractive errors, axial length (AXL) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.
- Conditions
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| e-book | study the course materials by using e-book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in refractive errors
cycloplegic autorefraction
Measured: 2 years
Secondary outcomes (2)
changes in axial length
measured by the Zeiss IOLMaster after cycloplegia
Measured: 2 years
Keratometric changes
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 posted29 May 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionFeb 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Responsible party
- Principal investigator, Carly Lam, The Hong Kong Polytechnic University
- Investigators
- Carly SY Lam, Professor, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150421
- Sponsor's protocol ID
- TWGHs
- Other IDs
- TWGHs2013
- Status last verified
- Jun 2016
- First submitted
- 26 May 2014
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren
- ClinicalTrials.gov ID
- NCT02150421
- Acronym / sponsor ID
- TWGHs
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 May 2014 (estimated)
- 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 aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function.
Detailed description
With the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. Parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology.
This is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren.
The schools will introduce e-books to their students in some classes. Signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. Eye examination and data collection will be conducted in primary school campus. The children from two local primary schools in same grade will be assigned into two groups by their schools. One group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). Their refractive errors, axial length (AXL) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e-book | – | –study the course materials by using e-book |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary schoolchildren in Hong Kong
Key inclusion criteria (2 listed)
- Chinese
- study local primary schools
Key exclusion criteria (3 listed)
- with any ocular diseases and binocular anomalies might affect visual functions or refractive development
- with history of eye surgery
- have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-K, eyedrops (e.g. atropine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in refractive errors
Time frame: 2 years
cycloplegic autorefraction
2 secondary outcomes
changes in axial length
Time frame: 2 years
Keratometric changes
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 22 Jun 2016.
- 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.
Carly SY Lam, Professor principal investigator
School of Optometry, 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?
An observational study of Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
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 2 inclusion and 3 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 22 Jun 2016. 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 China. 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?
Changes in refractive errors (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 22 Jun 2016.