NCT05894382进行中（未招募）不适用
A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Spherical Equivalent change
研究概览
简要总结
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Race: Chinese children and adolescents.
- •Age 6-13 years, gender unrestricted.
- •Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- •Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
- •Refractive astigmatism and astigmatism are no more than 1.5D.
- •During the study period, willing to wear glasses provided by the researcher only (>10 hours) and without additional interventions.
- •Willing to be randomly assigned.
- •Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
排除标准
- •Allergic or intolerant to medications used for ciliary muscle paralysis.
- •Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
- •Received defocus lenses for nearsightedness treatment in the past.
- •Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- •History of eye surgery (including strabismus correction surgery).
- •Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
- •Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
- •Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
结局指标
主要结局
Spherical Equivalent change
时间窗: 1 year
cycloplegic SE change
次要结局
- Axial Length change(1 year)
- Visual Acuity change(1 year)
研究者
研究点 (1)
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