Clinical trial NCT06652594: "Eye" Education for Parents and Myopia Control in Children
Official title: Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Children
Health Education
Anxiety
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 498
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria

1. Children aged 5-17;
2. 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;
3. Best corrected visual acuity of either eye were all ≥ 1.0;
4. The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
5. Astigmatism of either eye less than -5.0 D;
6. Anisometropia ≤ -1.5 D;
7. There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
8. Intraocular pressure of either eye is of 10 to 21 mmHg;
9. On the basis of full understanding, children and their guardians sign the informed consent;

Exclusion Criteria:

1. Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
2. Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
3. Secondary myopia, genetic disease or connective tissue- related myopia;
4. Moderate or severe ptosis;
5. Congenital cataract, glaucoma;
6. Other fundus diseases other than myopic related fundus lesions;
7. Intraocular or refractive surgery history;
8. 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.

Primary outcomes:
measure: Axial Length
timeFrame: Baseline, 1 month, 3 months, 6 months.
measure: Cycloplegic Refraction
timeFrame: Baseline, 1 month, 3 months, 6 months.
Secondary outcomes:
measure: Visual acuity
timeFrame: Baseline, 1 month, 3 months, 6 months.
measure: Anxiety Disorder Screening 7-item Scale
timeFrame: Baseline, 6 month
measure: Strengths and Difficulties Questionnaire
timeFrame: Baseline, 6 month.
Other outcomes:
measure: Fundus Image
timeFrame: Baseline, 1 month, 3 months, 6 months.
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Beijing
state: Beijing
Study officials:
References: