Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

Not Applicable

Completed

• Conditions: Myopia Progressing

• Registration Number: NCT06926556
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-09-28
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Age: 6-14 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria

1. Diagnosed constant strabismus;
2. Diagnosed pathological myopia;
3. Other congenital eye diseases;
4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective refraction equivalent spherical	2 years

Secondary Outcome Measures

Name	Time	Method
Axial length	2 years

Trial Locations

Locations (1)

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University; 🇨🇳 Shanghai, Shanghai, China