Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

Shanghai Eye Disease Prevention and Treatment Center

Status: Active, not recruiting

Conditions: Myopia Progressing

Treatments: Device: Functional lens

Study type: Interventional

Funder types: Other

Identifiers

NCT06927414

XSKHR2024-058-006

Details and patient eligibility

About

This study aims to evaluate the effectiveness of lenses with light diffraction glasses in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.

Enrollment: 40 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 6-8 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-1.75D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0;
3. Within 6 months, 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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40 participants in 2 patient groups

Light diffraction lens (Diffractive Optical Element , D.O.E)

Experimental group

Treatment:

Device: Functional lens

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

Active Comparator group

Treatment:

Device: Functional lens