Clinical trial NCT06411717: A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Official title: A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Suzhou Kerui Medical Technology Co., Ltd
Sponsor class: OTHER
Collaborators: name: Suzhou Mingshi Optical Technology Co., Ltd
First posted: 2024-05-13
Enrollment: 156
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change value of equivalent spherical lens after cycloplegia (subjective refraction)
timeFrame: After 12 months of wearing glasses
Secondary outcomes:
measure: Equivalent spherical lens strength after ciliary paralysis (subjective optometry)
timeFrame: Screening period and wearing glasses for 3 months, 6 months, 12 months
measure: Axis length
timeFrame: Screening period and wearing glasses for 3 months, 6 months, 12 months
measure: Regulating sensitivity
timeFrame: Screening period and wearing glasses for 3 months, 6 months, 12 months
measure: Stereopsis
timeFrame: Screening period and wearing glasses for 3 months, 6 months, 12 months
measure: Corneal curvature
timeFrame: Screening period and wearing glasses for 3 months, 6 months, 12 months
measure: Subjective perception rating for wearing a mirror
timeFrame: 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
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: District, Suzhou City, Jiangsu Province
Study officials:
References: