NCT07021560招募中不适用
A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Wearability and Myopia Progression of ZEISS MyoCare Spectacle Lenses Versus Two ZEISS Single Vision Spectacle Lenses in Children With Myopia
ZEISS Vision Care1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wearability
研究概览
简要总结
This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error.
Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and sign a record of informed consent/assent;
- •at baseline, be within the age range of 7 to 13 years old inclusive;
- •be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D);
- •astigmatism ≤1.50D;
- •anisometropia of not more than 1.50D;
- •be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator;
- •have ocular findings deemed to be normal;
- •vision correctable to at least 0.8 or better in each eye with spectacles.
排除标准
- •Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
- •Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
- •Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
- •History of eye trauma or eye surgery
- •Amblyopia
- •Anisometropia of not more than 1.50D
- •Strabismus
- •History of use of myopia control interventions such as Orthokeratology or atropine 3 months prior to commencement of this trial.
- •Known allergy or intolerance to ingredients to cycloplegic eye-drops.
- •Currently enrolled in another clinical trial.
结局指标
主要结局
Wearability
时间窗: At 1-week, 2-week, 3 months and 6 months visits
Compliance (lens wearing time, hr/day) to study spectacle lenses wear
次要结局
- Myopia progression(At baseline, 3 months, and 6 months visits)
研究者
研究点 (1)
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