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

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

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06221592

Enrollment

252

Registered

2024-01-24

Start date

2024-03-01

Completion date

2026-12-31

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Progressive

Brief 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.

Interventions

DEVICEdefocus spectacle lenses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Axial length	2 years	The change of axial length.

Secondary

Measure	Time frame	Description
Subjective refraction equivalent spherical	2 years	The change of Subjective refraction equivalent spherical

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026