Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

Shanghai Eye Disease Prevention and Treatment Center

Status: Completed

Conditions: Myopia Progressing

Treatments: Device: Defocus microlenses

Study type: Interventional

Funder types: Other

Identifiers

NCT06926556

QX-2024-A-003

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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134 participants in 2 patient groups

H.M.E.C，High Precision Micro Encircle

Experimental group

Treatment:

Device: Defocus microlenses

H. A. L. T, highly aspheric lenslet technology

Active Comparator group