Evaluating defocusing lenses to slow down myopia in children

A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

This study is testing if special defocusing lenses can help slow down worsening eyesight in children and teens aged 8 to 13.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 8 Years to 13 Years
• Sex: All
• Sponsor: Suzhou Care-Real Medical Technology Co., Ltd. (Academic / other)
• Locations: 1 site (Suzhou, District, Suzhou City, Jiangsu Province)
• Trial ID: NCT06411717 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of defocusing lenses in delaying the progression of myopia among children and adolescents aged 8 to 13. A total of 156 participants will wear either defocus lens A, defocus lens B, or a control aspheric lens for a duration of 12 months. Regular follow-ups will include various ophthalmological examinations and subjective assessments to monitor the lenses' performance and any adverse effects. The study will continuously observe ocular conditions and any serious adverse events to ensure the safety and effectiveness of the lenses.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 8 to 13 with myopia ranging from -1.00D to -6.00D.

Not a fit: Patients with a history of eye trauma or intraocular surgery, or those with abnormal slit-lamp examination results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new method to effectively slow down myopia progression in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Other studies have explored similar approaches with varying degrees of success, indicating potential for this method but also highlighting the need for further investigation.

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.

Where this trial is running

Suzhou, District, Suzhou City, Jiangsu Province

• The First Affiliated Hospital of Soochow University — Suzhou, District, Suzhou City, Jiangsu Province, China (Recruiting)

Study contacts

• Study coordinator: Jingyan Yao

Conditions Myopia