A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change value of equivalent spherical lens after cycloplegia (subjective refraction)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Change value of equivalent spherical lens after cycloplegia (subjective refraction)
时间窗: 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.
次要结局
- Axis length(Screening period and wearing glasses for 3 months, 6 months, 12 months)
- Equivalent spherical lens strength after ciliary paralysis (subjective optometry)(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)
- 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)