MyopiaNCT02980445
Time Outdoors as an Intervention for Myopia in Children
A study testing Outdoor activity 1 and Outdoor activity 2 in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Myopia
- What is being tested?
- Outdoor activity 1 and Outdoor activity 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2019
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at baseline be enrolled in grade 1 and 2 of primary schools;
- have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
- Children verbally consent when registration for examination
Who cannot join
- Any systemic or ocular pathology that may affect the refractive error status of the eye;
- Strabismus and amblyopia;
- Intellectual disability;
- Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
- Not suitable for inclusion in the study as deemed by the investigator.
About this study
Official title: Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.
Read the detailed description
- To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
- To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
- To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.
- Conditions
- Myopia
- Being tested
- Outdoor activity 1, Outdoor activity 2
- Keywords
- Myopia, Outdoor time, Children, Intervention, Prevention
- 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 1Behavioural
40-minute outdoor activity
Outdoor activity 2Behavioural
Dose 1 plus an additional 40-minute outdoor activities during recesses
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Outdoor Activity 1 | Experimental | 40min outdoor time in total. Receives: Behavioral: Outdoor activity 1 |
| Outdoor Activity 2 | Experimental | 80min outdoor time in total Receives: Behavioral: Outdoor activity 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refractive power（auto-refractor instrument）
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
Measured: 1 year
Secondary outcomes (1)
Axial length(IOL Master instrument)
The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brien Holden Vision
- Responsible party
- Sponsor
- Investigators
- Xun Xu, MD, Principal investigator, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980445
- Sponsor's protocol ID
- SHEH-M001
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang J, Sankaridurg P, Naduvilath T, Li W, Morgan IG, Rose KA, Weng R, Xu X, He X. Time outdoors positively associates with academic performance: a school-based study with objective monitoring of outdoor time. BMC Public Health. 2023 Apr 4;23(1):645. doi: 10.1186/s12889-023-15532-y.
PubMed 37016357Gong W, Cheng T, Wang J, Zhang B, Chen J, Zhu J, Zou H, Liu K, He X, Xu X. Role of corneal radius of curvature in early identification of fundus tessellation in children with low myopia. Br J Ophthalmol. 2023 Oct;107(10):1532-1537. doi: 10.1136/bjo-2022-321295. Epub 2022 Jul 26.
PubMed 35882514He X, Sankaridurg P, Wang J, Chen J, Naduvilath T, He M, Zhu Z, Li W, Morgan IG, Xiong S, Zhu J, Zou H, Rose KA, Zhang B, Weng R, Resnikoff S, Xu X. Time Outdoors in Reducing Myopia: A School-Based Cluster Randomized Trial with Objective Monitoring of Outdoor Time and Light Intensity. Ophthalmology. 2022 Nov;129(11):1245-1254. doi: 10.1016/j.ophtha.2022.06.024. Epub 2022 Jun 30.
PubMed 35779695
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02980445
- Acronym / sponsor ID
- SHEH-M001
- Conditions
- Myopia
- Keywords
- Myopia, Outdoor time, Children, Intervention, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Brien Holden Vision
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 2 Dec 2016 (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 to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.
Detailed description
- To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
- To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
- To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Outdoor Activity 1 | Experimental | Behavioral: Outdoor activity 140min outdoor time in total. |
| Outdoor Activity 2 | Experimental | Behavioral: Outdoor activity 280min outdoor time in total |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- at baseline be enrolled in grade 1 and 2 of primary schools;
- have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
- Children verbally consent when registration for examination
Key exclusion criteria (5 listed)
- Any systemic or ocular pathology that may affect the refractive error status of the eye;
- Strabismus and amblyopia;
- Intellectual disability;
- Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
- Not suitable for inclusion in the study as deemed by the investigator.
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 140-minute outdoor activity | Behavioural | Outdoor Activity 1 |
| Outdoor activity 2Dose 1 plus an additional 40-minute outdoor activities during recesses | Behavioural | Outdoor Activity 2 |
Primary outcome
Cycloplegic refractive power（auto-refractor instrument）
Time frame: 1 year
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
1 secondary outcome
Axial length(IOL Master instrument)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Derived from this study: PubMed 37016357Wang J, Sankaridurg P, Naduvilath T, Li W, Morgan IG, Rose KA, Weng R, Xu X, He X. Time outdoors positively associates with academic performance: a school-based study with objective monitoring of outdoor time. BMC Public Health. 2023 Apr 4;23(1):645. doi: 10.1186/s12889-023-15532-y.
- Derived from this study: PubMed 35882514Gong W, Cheng T, Wang J, Zhang B, Chen J, Zhu J, Zou H, Liu K, He X, Xu X. Role of corneal radius of curvature in early identification of fundus tessellation in children with low myopia. Br J Ophthalmol. 2023 Oct;107(10):1532-1537. doi: 10.1136/bjo-2022-321295. Epub 2022 Jul 26.
- Derived from this study: PubMed 35779695He X, Sankaridurg P, Wang J, Chen J, Naduvilath T, He M, Zhu Z, Li W, Morgan IG, Xiong S, Zhu J, Zou H, Rose KA, Zhang B, Weng R, Resnikoff S, Xu X. Time Outdoors in Reducing Myopia: A School-Based Cluster Randomized Trial with Objective Monitoring of Outdoor Time and Light Intensity. Ophthalmology. 2022 Nov;129(11):1245-1254. doi: 10.1016/j.ophtha.2022.06.024. Epub 2022 Jun 30.
- 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.
Xun Xu, MD principal investigator
Shanghai Eye Disease Prevention and Treatment Center
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor activity 1 and Outdoor activity 2 in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 refractive power（auto-refractor instrument） (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980445, which also lists 3 linked publications.
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 2 Dec 2016.