NCT06034327招募中不适用
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 28
- 主要终点
- Spherical equivalent refraction
研究概览
简要总结
This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.
This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
- •Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
- •Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
- •Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
- •The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
- •Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
- •Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
- •Willingness to participate in the trial for 24 months without contact lens wear;
- •The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
排除标准
- •Subject has previously or currently wears contact lenses (greater than 1-month usage);
- •Current or prior use of bifocals, progressive addition spectacle lenses
- •Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
- •Amblyopia in either eye;
- •Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
- •Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)];
- •Known allergy to proparacaine, tetracaine, or tropicamide;
- •Participation in any investigational clinical study within 30 days of the Baseline visit;
- •Subject's sibling or other household member is already enrolled in this trial.
结局指标
主要结局
Spherical equivalent refraction
时间窗: 12 months
Change in spherical equivalent refraction from baseline
次要结局
- Axial length(12 months)
研究者
研究点 (28)
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