Status:
ACTIVE_NOT_RECRUITING
Early Intervention for Premyopic Children
Lead Sponsor:
National Yang Ming Chiao Tung University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Myopia
Preschool
Eligibility:
All Genders
5-6 years
Phase:
PHASE2
Brief Summary
The purpose of this research project is to add evidence of pharmacological (0.01% atropine) and optical (Defocus Integrated Multiple Segments spectacle lenses) approaches for myopia prevention among p...
Detailed Description
With more popularity of screen-based digital devices in the post-pandemic era, childhood myopia prevention and control has encountered a tough challenge on a global scale. Though the protective effect...
Eligibility Criteria
Inclusion
- Age at enrollment: 5-6 years old (the senior grade of kindergarten)
- Cycloplegic SE of the eye with less SE (less positive or more negative refractive error): \< +1.00 D and \> -0.50 D
- Astigmatism: 1.0 D or less in both eyes
- Anisometropia: 1.50 D or less
- Monocular uncorrected visual acuity: 6/7.5 or better in both eyes
- Either of the parents with moderate myopia
- Acceptance of random group allocation
- Submission of complete informed consent.
Exclusion
- Strabismus or any ocular motility disorder
- Any ophthalmic and systemic disorders that might affect visual functions or refractive development
- Previous treatment of atropine or other myopia control intervention
Key Trial Info
Start Date :
October 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06200194
Start Date
October 6 2024
End Date
July 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
National Yang Ming Chiao Tung University Hospital
Yilan, Taiwan, Taiwan, 26058