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

Not Applicable

• Conditions: Myopia, Progressive
• Interventions: Device: defocus spectacle lenses

• Registration Number: NCT06221592
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-17
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-24
• Study Start: 2024-03-01
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 252

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circular multi-point optical micro transparent defocus spectacle lenses	defocus spectacle lenses	-
Innovative micro defocus spectacle lenses	defocus spectacle lenses	-
Full axis multi-point defocus spectacle lenses	defocus spectacle lenses	-
High non spherical micro transparent defocus spectacle lenses	defocus spectacle lenses	-

Primary Outcome Measures

Name	Time	Method
Axial length	2 years	The change of axial length.

Secondary Outcome Measures

Name	Time	Method
Subjective refraction equivalent spherical	2 years	The change of Subjective refraction equivalent spherical

Trial Locations

Locations (1)

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University; 🇨🇳 Shanghai, Shanghai, China