MyopiaNCT05691296
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
A study testing Home training and School training in people with Myopia and High Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Myopia, High Myopia
- What is being tested?
- Home training and School training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2024
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All students in grades 1 to 4
- Can cooperate with the examination of students
Who cannot join
- Obvious strabismus and amblyopia
- Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
- History of ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.
Read the detailed description
The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.
- Conditions
- Myopia, High Myopia
- Being tested
- Home training, School training
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home trainingBehavioural
Letter Chart Accomodative Rock Training for 2 minutes each time
School trainingBehavioural
Letter Chart Accomodative Rock Training for 2 minutes each time
| Study group | Role | What they receive |
|---|---|---|
| Home-school training group | Experimental | There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time. Receives: Behavioral: Home training; Behavioral: School training |
| School training group | Experimental | There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time. Receives: Behavioral: School training |
| No training group | No intervention | There was no such treatment for students. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of new-onset myopia
The number of new children with myopia was counted
Measured: Through study completion, an average of 1 year
The changes of refractive error
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
Measured: Every 6 months, up to 3 years
The changes of axial length
The axial length was measured by a biological measuring instrument.
Measured: Every 6 months, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691296
- Sponsor's protocol ID
- Tianjin myopia Intervention
- Status last verified
- May 2024
- First submitted
- 25 Dec 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.
PubMed 33909032
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
- ClinicalTrials.gov ID
- NCT05691296
- Acronym / sponsor ID
- Tianjin myopia Intervention
- Conditions
- Myopia, High Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jan 2023 (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 study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.
Detailed description
The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-school training group | Experimental | Behavioral: Home training, Behavioral: School trainingThere was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time. |
| School training group | Experimental | Behavioral: School trainingThere was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time. |
| No training group | No intervention | –There was no such treatment for students. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All students in grades 1 to 4
- Can cooperate with the examination of students
Key exclusion criteria (3 listed)
- Obvious strabismus and amblyopia
- Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
- History of ocular surgery
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 |
|---|---|---|
| Home trainingLetter Chart Accomodative Rock Training for 2 minutes each time | Behavioural | Home-school training group |
| School trainingLetter Chart Accomodative Rock Training for 2 minutes each time | Behavioural | Home-school training group, School training group |
Primary outcome
The rate of new-onset myopia
Time frame: Through study completion, an average of 1 year
The number of new children with myopia was counted
The changes of refractive error
Time frame: Every 6 months, up to 3 years
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
The changes of axial length
Time frame: Every 6 months, up to 3 years
The axial length was measured by a biological measuring instrument.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 33909032Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.
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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 Home training and School training in people with Myopia and High Myopia, run by Tianjin Eye Hospital 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
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?
The rate of new-onset myopia (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT05691296, which also lists 1 linked publication.
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 May 2024.