NCT07686289尚未招募不适用
A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
Kubota Vision Inc.0 个研究点目标入组 35 人开始时间: 2026年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Axial length
研究概览
简要总结
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
- •Sign written Informed Consent (and the California Bill of Rights, if applicable).
- •Be between age 8-24 (inclusive) and able to understand and assent to participation.
- •Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
- •Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
- •Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better in each eye.
- •Be willing and able to follow instructions and attend the schedule of follow-up visits.
排除标准
- •Unable or unwilling to provide informed consent and assent.
- •Eye injury or surgery within twelve weeks immediately prior to enrollment.
- •Currently enrolled in an ophthalmic clinical trial.
- •Pregnant or lactating or expect to become pregnant during the trial (by self-report).
- •Evidence of systemic or ocular abnormality, infection or disease.
- •Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).
- •Anisometropia ≥ 2.
- •Subjects who have undergone corneal refractive surgery.
- •Use atropine or other anticholinergic drug within the past month.
- •Employees or immediate family members of employees of study sites or sponsor.
结局指标
主要结局
Axial length
时间窗: 1 hour
次要结局
未报告次要终点
研究者
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