NCT07566234招募中不适用
Myopia Prevention Study in Chinese Population With Dual Focus Myopia Control Lenses.
CooperVision International Limited (CVIL)1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年6月6日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children aged between 8-10 years inclusive.
- •Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
- •Astigmatism ≤ -1.00D in both eyes.
- •Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
- •As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms.
- •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 and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
- •Be in good general health, based on his/her and parent's/guardian's knowledge.
- •Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.
排除标准
- •History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
- •Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- •Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- •Ocular or systemic disease that contraindicates contact lens wear.
- •Active allergic conjunctivitis.
- •Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
- •Keratoconus or an irregular cornea.
- •History of clinically significant binocular vision abnormality or strabismus.
- •Any active anterior segment finding that would contraindicate contact lens wear.
- •The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
研究组 & 干预措施
Test Lens
Experimental
干预措施: Test Lens - Dual Focus (Device)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
EndoArt® Implantation in Subjects With Chronic Corneal Edema - US StudyNCT07344168Eye-yon Medical123
尚未招募
不适用
JOURNEY LVAD: JOURNEY Left Ventricular Assist DeviceAortic InsufficiencyNCT07363473JC Medical, Inc., an affiliate of Edwards Lifesciences LLC50
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT07456098[Redacted]
招募中
不适用
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord InjuryNCT07264868The University of Texas Health Science Center, Houston21
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT07406581[Redacted]