A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

NCT ID: NCT06411717

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-07
• Study Completion Date: 2026-03-07

Brief Summary

The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.

Conditions

Myopia

Study Design

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

Study Groups

Trial Group A

12-month defocusing lens (microstructured lens A)

Group Type: EXPERIMENTAL

Microstructure lens A

Intervention Type: DEVICE

Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months

Trial Group B

12-month defocusing lens (microstructured lens B)

Group Type: EXPERIMENTAL

Microstructure lens B

Intervention Type: DEVICE

Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months

Control group

12 months wearing aspherical lens

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months

Interventions

Microstructure lens A

Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months

Intervention Type: DEVICE

Microstructure lens B

Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months

Intervention Type: DEVICE

Control group

Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants must meet all criteria to be enrolled in the study at the screening visit:

1. Age 8~13 years old (including boundary values), gender is not limited;

2. The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D;

3. Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;

4. In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;

5. Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;

Exclusion Criteria

Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:

1. Have a history of eye trauma or intraocular surgery;

2. Abnormal results of slit-lamp examination (see Annex 1 for details);

3. fundus examination results ≥ grade 2 (see Annex 1 for details);

4. Intraocular pressure < 10mmHg or > 21mmHg or intraocular pressure difference ≥5mmHg;

5. Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumors, eye trauma, dominant strabismus, and any eye lesions affecting visual function;

6. Associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.);

7. suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses;

8. Use specially designed myopia control lenses such as hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, and atropine drugs within 1 month before screening or during the planned study period;

9. Participating in other clinical trials within 3 months prior to screening;

10. Those who cannot perform regular eye examination;

11. Other investigators consider it inappropriate to participate in this clinical study.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Mingshi Optical Technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Suzhou Kerui Medical Technology Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, District, Suzhou City, Jiangsu Province, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingyan Yao

Role: CONTACT

yaojingyan@suda.edu.cn

＋86 13862578532

Facility Contacts

Jingyan Yao

Role: primary

yaojingyan@suda.edu.cn

13862578532

Other Identifiers

MS-CTP

Identifier Type: -

Identifier Source: org_study_id