Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Spherical Equivalent Refraction (SER)
研究概览
简要总结
A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
- •Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
- •The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
- •Based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than Grade 2 (mild).
- •No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
- •Slit lamp findings must be less than Grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic.
- •There are no other active eye diseases that are not suitable for contact lens wear.
- •No topical eye drops are currently being used.
- •The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
- •Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
- •Meet the following refractive criteria determined by cycloplegic autorefraction at baseline
- •Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
- •Astigmatism: ≤-0.75 D
- •Anisometropia: <1.00 D
- •Exclusion criteria:
- •Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
- •Those who are unable to comply with regular tracking and inspection.
- •Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
- •Subject has undergone any eye surgery or corneal surgery.
- •Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
- •Those who are unable to cooperate with regular tracking and inspection.
- •Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.
排除标准
- 未提供
结局指标
主要结局
Spherical Equivalent Refraction (SER)
时间窗: 12 months
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
次要结局
- Axial Eye Length (AXL)(12 months)