Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

NCT ID: NCT06927414

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Myopia Progressing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Functional lens

Intervention Type: DEVICE

Diffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.

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

Group Type: ACTIVE_COMPARATOR

Functional lens

Intervention Type: DEVICE

Diffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.

Interventions

Functional lens

Diffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XSKHR2024-058-006

Identifier Type: -

Identifier Source: org_study_id