"Eye" Education for Parents and Myopia Control in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eye Education Intervention, Control.
- Who it may be relevant to
- Registry conditions: Children, Health Education, Anxiety. Basic parameters: 5 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
Overview
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.
Interventions
- Behavioral Eye Education Intervention
Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months. - Behavioral Control
Parents in the control group will not receive eye health education informationfrom doctors and nurses.
Primary outcome measures
- Axial Length [Time frame: Baseline, 1 month, 3 months, 6 months.]
- Cycloplegic Refraction [Time frame: Baseline, 1 month, 3 months, 6 months.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
- 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;
- 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;
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing Tongren Hospital, Beijing — Beijing
Identifiers
NCT: NCT06652594 · 2024-2G-1081