Comparative Efficacy and Safety of Multi-Type Photolithography Flat Microstructure Spectacle Lenses Versus Spectacle Lenses With Aspherical Lenslets for Myopia Control in Chinese Children: A 12-Month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months.
研究概览
简要总结
The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:
Are photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.
Participants will:
Wear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.
Visit the clinic once every 3 months for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
- •The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
- •Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
- •Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
- •Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);
- •General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs;
- •Previous intervention: No use of any myopia control methods within the past 3 months, including but not limited to: multifocal glasses, atropine eye drops, red light therapy, acupuncture, etc.
- •Compliance with spectacle wear: Parents ensure that the child wears glasses for ≥8 hours per day;
- •Follow-up capability: Ability to attend scheduled follow-ups for 12 months (4 visits in total);
- •Informed consent from guardian: Legal guardian signs the informed consent form; children also sign the assent form.
排除标准
- •History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;
- •Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;
- •Used any myopia intervention drugs or devices in the past 3 months;
- •Those who have participated in other similar clinical studies in the past 3 months;
- •Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases;
- •Those who are allergic to the lens material or products related to the study;
- •Allergy to mydriatic agents and related ophthalmic medications;
- •Allergic to photochromic materials or related dyes; taking photosensitizing drugs; suffering from photo-induced skin or neurological disorders;
- •Unable to understand the study content or unable to cooperate with the follow-up;
- •Other reasons why the research doctor believes the patient is not suitable for the study.
研究组 & 干预措施
PPML(multi-point defocus design, non-fading, Nuo Tong)
The group wears photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property.
干预措施: wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property (Device)
PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong)
PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation.
干预措施: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation (Device)
PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong)
PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation.
干预措施: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation (Device)
PPML (designed to reduce contrast, non-fading, Nuo Tong)
PPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property
干预措施: wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property (Device)
Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest)
Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)
干预措施: wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) (Device)
结局指标
主要结局
Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months.
时间窗: From enrollment to the end of treatment at 12 month
Computerized refractometer testing, The formula for calculating sphere equivalent power: sphere power + 0.5 \* cylinder power
次要结局
- Difference in 12-month axial length (AL, mm) from baseline(From enrollment to the end of treatment at 12 month)