Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses

Shanghai Eye Disease Prevention and Treatment Center

Status: Not yet enrolling

Conditions: Myopia, Progressive

Treatments: Device: defocus spectacle lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT06221592

QX-2023-A-03

Details and patient eligibility

About

To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.

Enrollment: 252 estimated 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 0.00D~-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: Single Blind

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252 participants in 4 patient groups, including a placebo group

Full axis multi-point defocus spectacle lenses

Experimental group

Treatment:

Device: defocus spectacle lenses

Innovative micro defocus spectacle lenses

Experimental group

Treatment:

Device: defocus spectacle lenses

Circular multi-point optical micro transparent defocus spectacle lenses

Experimental group

Treatment:

Device: defocus spectacle lenses

High non spherical micro transparent defocus spectacle lenses

Placebo Comparator group

Treatment:

Device: defocus spectacle lenses