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

Myopia, Progressive Clinical Trial

Official title:

Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221592
• Other study ID #: QX-2023-A-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• defocus spectacle lenses
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	The change of axial length.	2 years
Secondary	Subjective refraction equivalent spherical	The change of Subjective refraction equivalent spherical	2 years