NCT05273606进行中（未招募）不适用
A Clinical Study of Short-term Clinical Performance of Multifocal Soft Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
研究概览
简要总结
The study is aimed to observe the short-term clinical performance of MiSight™ multifocal soft contact lens compared with Proclear™ 1day, including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses.
详细描述
Compared with Proclear™ 1day, observe the short-term clinical performance of MiSight™ multifocal soft contact lens including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses in 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Prior to being considered eligible to participate in this study, each subject MUST:
- •Be between 8 and 12 years of age inclusive at the baseline examination.
- •read the Informed Assent,
- •been given an explanation of the Informed Assent,
- •indicated an understanding of the Informed Assent and
- •signed the Informed Assent Form.
- •Have their parent or legal guardian:
- •read the Informed Consent,
- •been given an explanation of the Informed Consent,
- •indicated an understanding of the Informed Consent and
- •signed the Informed Consent Form.
- •Along with their parent or guardian, be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
- •Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
- •Agree to wear the assigned contact lenses for the duration of the 1-month study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
- •Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:
- •Spherical refractive error： between -0.75 and -4.00 D inclusive,
- •Astigmatism: ≤-0.75 D,
- •Anisometropia: ≤1.50D,
- •Best-corrected visual acuity :≥0.8.
排除标准
- •• Subjects may not be considered eligible if ANY of the following apply:
- •Subject has regular use of ocular medications.
- •Any systemic disease which is not suggested to wear contact lens or current use of systemic medications which may significantly affect contact lens wear, visual function, or refractive state.
- •A history of ocular trauma or ocular surgery in the last 8 weeks.
- •Subject has worn rigid gas permeable contact lenses in the last 6 weeks, including orthokeratology lenses.
- •Abnormal secretion or excretion of tear fluid, infection of the tear ducts, or other recurrent ocular infections.
- •A known allergy to fluorescein, benoxinate, proparacaine, or tropicamide.
- •Keratoconus or an irregular cornea.
- •Subjects who have been in a special environment such as dryness, serious dust, or volatile chemicals for a long time affect the wear of contact lenses.
- •Strabismus, amblyopia patients, only one eye meets the admission conditions.
- •Subjects have received any myopia control treatment.
- •Subject is currently an active participant in another clinical study.
结局指标
主要结局
Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
时间窗: Proclear baseline;VMisight baseline; 1 week; 1month
次要结局
- Doctors' clinical evaluation to multifocal soft contact lens(Proclear baseline; Misight baseline; 1 week; 1month)
- Change in the contact lens corrected visual acuity relative to baseline(Proclear baseline;Misight baseline；1 week;1month)
- Patients' subjective acceptability to multifocal soft contact lens(Proclear baseline; Misight baseline; 1 week; 1month)
研究者
Xiao Yang
Principal Investigator, Clinical Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University
研究点 (1)
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