ChildrenNCT06652594
"Eye" Education for Parents and Myopia Control in Children
A study testing Eye Education Intervention in people with Children and Health Education, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Health Education, Anxiety
- What is being tested?
- Eye Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2024to 19 Apr 2025
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-17;
- Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
- Best corrected visual acuity of either eye were all ≥ 1.0;
- The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
- Astigmatism of either eye less than -5.0 D;
- Anisometropia ≤ -1.5 D;
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- There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
- Intraocular pressure of either eye is of 10 to 21 mmHg;
- On the basis of full understanding, children and their guardians sign the informed consent;
Who cannot join
- Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
- Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
- Secondary myopia, genetic disease or connective tissue- related myopia;
- Moderate or severe ptosis;
- Congenital cataract, glaucoma;
- Other fundus diseases other than myopic related fundus lesions;
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- Intraocular or refractive surgery history;
- The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;
- (10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Beijing
Beijing, Beijing Municipality, 100730
Shi-Ming Li, MD, PHD, +86-010-58269920, lishiming81@163.com
Shi-Ming Li, MD, PHD
About this study
Official title: Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.
Read the detailed description
After doctors' and nurses' education, parents would keep a diary to regulate the children's "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children's eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.
- Conditions
- Children, Health Education, Anxiety
- Being tested
- Eye Education Intervention, Control
- Medical subject headings
- Health Education, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Education InterventionBehavioural
Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.
ControlBehavioural
Parents in the control group will not receive eye health education informationfrom doctors and nurses.
| Study group | Role | What they receive |
|---|---|---|
| Eye Education Intervention | Experimental | Doctors and nurses will educate parents about eye health in response to their child's myopia progression at baseline, 1 month, 3 months, 6 months. Receives: Behavioral: Eye Education Intervention |
| Control | Experimental | Parents in the control group will not receive eye health education information from doctors and nurses. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
Ocular biometry was used for measuring the axial length, which is the physical distance between the anterior corneal pole and the retinal structure at the posterior pole.
Measured: Baseline, 1 month, 3 months, 6 months.
Cycloplegic Refraction
Cycloplegic refractive errors were measured with an autorefractor.
Measured: Baseline, 1 month, 3 months, 6 months.
Secondary outcomes (3)
Visual acuity
The visual acuity of the children is assessed through a self-administered vision test conducted by their guardians via WeChat mini program.
Measured: Baseline, 1 month, 3 months, 6 months.
Anxiety Disorder Screening 7-item Scale
Assessing changes in parents' anxiety before and after the intervention.
Measured: Baseline, 6 month
Strengths and Difficulties Questionnaire
Assessing changes in parent-child relationships before and after the intervention.
Measured: Baseline, 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start19 Oct 2024 (estimated)
- Primary completion19 Apr 2025 (estimated)
- Study completion19 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Li, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652594
- Sponsor's protocol ID
- 2024-2G-1081
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
- ClinicalTrials.gov ID
- NCT06652594
- Acronym / sponsor ID
- 2024-2G-1081
- Conditions
- Children, Health Education, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 19 Oct 2024 (estimated)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 19 Apr 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.
Detailed description
After doctors' and nurses' education, parents would keep a diary to regulate the children's "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children's eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Education Intervention | Experimental | Behavioral: Eye Education InterventionDoctors and nurses will educate parents about eye health in response to their child's myopia progression at baseline, 1 month, 3 months, 6 months. |
| Control | Experimental | Behavioral: ControlParents in the control group will not receive eye health education information from doctors and nurses. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 5-17;
- Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
- Best corrected visual acuity of either eye were all ≥ 1.0;
- The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
- Astigmatism of either eye less than -5.0 D;
Key exclusion criteria (9 listed)
- Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
- Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
- Secondary myopia, genetic disease or connective tissue- related myopia;
- Moderate or severe ptosis;
- Congenital cataract, glaucoma;
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 |
|---|---|---|
| Eye Education InterventionDoctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months. | Behavioural | Eye Education Intervention |
| ControlParents in the control group will not receive eye health education informationfrom doctors and nurses. | Behavioural | Control |
Primary outcome
Axial Length
Time frame: Baseline, 1 month, 3 months, 6 months.
Ocular biometry was used for measuring the axial length, which is the physical distance between the anterior corneal pole and the retinal structure at the posterior pole.
Cycloplegic Refraction
Time frame: Baseline, 1 month, 3 months, 6 months.
Cycloplegic refractive errors were measured with an autorefractor.
3 secondary outcomes
Visual acuity
Time frame: Baseline, 1 month, 3 months, 6 months.
Anxiety Disorder Screening 7-item Scale
Time frame: Baseline, 6 month
Strengths and Difficulties Questionnaire
Time frame: Baseline, 6 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Education Intervention in people with Children and Health Education, run by Beijing Tongren 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 9 inclusion and 9 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 22 Oct 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?
Contact Shi-Ming Li, MD, PHD (+86-010-58269920, lishiming81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Length (time frame: Baseline, 1 month, 3 months, 6 months.). The study lists 2 primary outcomes in all. 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 Oct 2024.