"Eye" Education for Parents and Myopia Control in Children
Effect of "eye" Education for Parents on Myopia Prevention and Control in Children
1 other identifier
interventional
498
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2024
CompletedFirst Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2025
CompletedOctober 22, 2024
October 1, 2024
6 months
October 21, 2024
October 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, 1 month, 3 months, 6 months.
Cycloplegic Refraction
Cycloplegic refractive errors were measured with an autorefractor.
Baseline, 1 month, 3 months, 6 months.
Secondary Outcomes (3)
Visual acuity
Baseline, 1 month, 3 months, 6 months.
Anxiety Disorder Screening 7-item Scale
Baseline, 6 month
Strengths and Difficulties Questionnaire
Baseline, 6 month.
Other Outcomes (1)
Fundus Image
Baseline, 1 month, 3 months, 6 months.
Study Arms (2)
Eye Education Intervention
EXPERIMENTALDoctors 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
EXPERIMENTALParents in the control group will not receive eye health education information from doctors and nurses.
Interventions
Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.
Parents in the control group will not receive eye health education informationfrom doctors and nurses.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tongren Hospital, Beijing
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 21, 2024
First Posted
October 22, 2024
Study Start
October 19, 2024
Primary Completion
April 19, 2025
Study Completion
April 19, 2025
Last Updated
October 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share