Actively Recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Led by Suzhou Care-Real Medical Technology Co., Ltd. · Updated on 2024-05-14
156
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
S
Suzhou Care-Real Medical Technology Co., Ltd.
Lead Sponsor
S
Suzhou Mingshi Optical Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and 13 years old, any gender
- Spherical degree between -1.00D and -6.00D in both eyes after cycloplegic subjective refraction
- Equivalent spherical difference between both eyes less than 1.50D
- Corrected visual acuity of 1.0 or better in both eyes after cycloplegia
- Cylinder degree in both eyes with cycloplegia less than or equal to 1.50D
- Voluntary participation with signed informed consent and guardian's written consent
You will not qualify if you...
- History of eye trauma or intraocular surgery
- Abnormal slit-lamp examination results
- Fundus examination results grade 2 or higher
- Intraocular pressure less than 10mmHg or greater than 21mmHg or difference greater than 5mmHg
- Other eye diseases affecting vision such as uveitis, glaucoma, cataract, eye tumors, dominant strabismus, or any eye lesions
- Associated diseases affecting the eye like sinusitis, diabetes, Down syndrome, rheumatoid arthritis
- Mental disorders or other diseases unsuitable for wearing glasses
- Use of specially designed myopia control lenses or atropine drugs within 1 month before screening or during the study
- Participation in other clinical trials within 3 months prior to screening
- Inability to perform regular eye examinations
- Any condition the investigator considers unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, District, Suzhou City, Jiangsu Province, China
Actively Recruiting
Research Team
J
Jingyan Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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