MyopiaNCT02082743
Vision Care Intervention for Lower Grade School Children in Taiwan
A study testing Outdoor activity in recess time in people with Myopia and Outdoor Activity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Myopia, Outdoor Activity, Policy of Recess Outside Classroom
- What is being tested?
- Outdoor activity in recess time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Feb 2015
- 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 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the students in Grade 1
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine
Kaohsiung City
About this study
Official title: Intervention Program for Vision Care in Lower Grade Schoolchildren
The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.
- Conditions
- Myopia, Outdoor Activity, Policy of Recess Outside Classroom
- Being tested
- Outdoor activity in recess time
- Keywords
- Myopia, Outdoor activity, Recess outside classroom
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor activity in recess timeBehavioural
Outdoor activity in recess time
| Study group | Role | What they receive |
|---|---|---|
| Outdoor activity | Experimental | Outdoor activity in recess time Receives: Behavioral: Outdoor activity in recess time |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction
Measured: 1 year
Secondary outcomes (1)
Axial length
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 Chang Gung Memorial HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082743
- Sponsor's protocol ID
- C1020515
- Other IDs
- HPA-MHW-C1020515
- Status last verified
- Jul 2015
- First submitted
- 23 Feb 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Program for Vision Care in Lower Grade Schoolchildren
- ClinicalTrials.gov ID
- NCT02082743
- Acronym / sponsor ID
- C1020515
- Conditions
- Myopia, Outdoor Activity, Policy of Recess Outside Classroom
- Keywords
- Myopia, Outdoor activity, Recess outside classroom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Mar 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 purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor activity | Experimental | Behavioral: Outdoor activity in recess timeOutdoor activity in recess time |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the students in Grade 1
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Outdoor activity in recess timeOutdoor activity in recess time | Behavioural | Outdoor activity |
Primary outcome
Cycloplegic refraction
Time frame: 1 year
1 secondary outcome
Axial length
Time frame: 1 year
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 7 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor activity in recess time in people with Myopia and Outdoor Activity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 7 Aug 2015. 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 Taiwan. 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: 1 year). 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 7 Aug 2015.