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

Not Applicable

Recruiting

• Conditions: Myopia

• Registration Number: NCT06411717
• Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-07
• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-11
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-11-07
• Study Completion: 2026-03-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change value of equivalent spherical lens after cycloplegia (subjective refraction)	After 12 months of wearing glasses	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.

Secondary Outcome Measures

Name	Time	Method
Axis length	Screening period and wearing glasses for 3 months, 6 months, 12 months	The length of the eye axis was measured by the researcher and the corresponding value was recorded.
Equivalent spherical lens strength after ciliary paralysis (subjective optometry)	Screening period and wearing glasses for 3 months, 6 months, 12 months	The subjects were subjected to subjective refraction after ciliary paralysis by the investigator, and the corresponding value of equivalent spherical mirror was recorded.
Regulating sensitivity	Screening period and wearing glasses for 3 months, 6 months, 12 months	The researchers conducted sensitivity adjustment tests on the subjects and recorded the test results.
Stereopsis	Screening period and wearing glasses for 3 months, 6 months, 12 months	The researchers tested the subjects' near-stereoscopic vision and recorded the test results.
Corneal curvature	Screening period and wearing glasses for 3 months, 6 months, 12 months	The subjects were examined for corneal curvature by the investigator and the results were recorded.
Subjective perception rating for wearing a mirror	On the day of wearing the glasses and 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after wearing the glasses	According to their subjective feelings, the subjects were evaluated by Visual Analogue Scales (VAS). The VAS score is on a 10cm scale marked with the words "0" and "10" at each end. "0" is comfortable, "10" is unbearable.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, District, Suzhou City, Jiangsu Province, China