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

NCT06411717 | Recruiting

• 1 other identifier: MS-CTP
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change value of equivalent spherical lens after cycloplegia (subjective refraction)

  Subjective optometry after ciliary paralysis was measured by blind researchers (who did not participate in the screening and treatment of subjects), and the final equivalent spherical degree was recorded, and the difference between the subjective optometric equivalent spherical results after ciliary paralysis in the baseline period (before wearing lenses) was recorded.

  After 12 months of wearing glasses

Secondary Outcomes (6)

• Equivalent spherical lens strength after ciliary paralysis (subjective optometry)

  Screening period and wearing glasses for 3 months, 6 months, 12 months

• Axis length

  Screening period and wearing glasses for 3 months, 6 months, 12 months

• Regulating sensitivity

  Screening period and wearing glasses for 3 months, 6 months, 12 months

• Stereopsis

  Screening period and wearing glasses for 3 months, 6 months, 12 months

• Corneal curvature

  Screening period and wearing glasses for 3 months, 6 months, 12 months

Study Arms (3)

Trial Group A

EXPERIMENTAL

12-month defocusing lens (microstructured lens A)

Device: Microstructure lens A

Trial Group B

EXPERIMENTAL

12-month defocusing lens (microstructured lens B)

Device: Microstructure lens B

Control group

ACTIVE COMPARATOR

12 months wearing aspherical lens

Other: Control group

Interventions

Microstructure lens A 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 A

Microstructure lens B DEVICE

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

Trial Group B

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must meet all criteria to be enrolled in the study at the screening visit:
• Age 8\~13 years old (including boundary values), gender is not limited;
• 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;
• Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;
• In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;
• Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;

You may not qualify if:

• Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:
• Have a history of eye trauma or intraocular surgery;
• Abnormal results of slit-lamp examination (see Annex 1 for details);
• fundus examination results ≥ grade 2 (see Annex 1 for details);
• Intraocular pressure \< 10mmHg or \> 21mmHg or intraocular pressure difference ≥5mmHg;
• 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;
• Associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.);
• suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses;
• 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;
• Participating in other clinical trials within 3 months prior to screening;
• Those who cannot perform regular eye examination;
• Other investigators consider it inappropriate to participate in this clinical study.

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead
• Suzhou Mingshi Optical Technology Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, District, Suzhou City, Jiangsu Province, China

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Jingyan Yao

CONTACT

＋86 13862578532; yaojingyan@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: April 7, 2024
• Primary Completion: November 7, 2025
• Study Completion: March 7, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (1)