NCT07155551招募中不适用
Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour
Myoptechs, Inc1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月25日最近更新:
适应症
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
- 20
- 试验地点
- 1
- 主要终点
- Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear
研究概览
简要总结
The objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18-25 years of age (inclusive) and have full legal capacity to volunteer; Have read (or be read to) and signed the information and consent form; Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear;
- •Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS;
- •Achieve at least LogMAR +0.10 with spherical equivalent refraction in each eye;
- •Are willing and able to maintain the appointment schedule and follow the measurement visit instructions which include no use of caffeine drinks, alcohol or other stimulants 12 hours before each measurement visit and no smoking or use of recreational cannabis 24 hours before the study visit;
- •Have not used a myopia control treatment within 2 years prior to Visit 0 (this includes multifocal spectacle or contact lens wear, orthokeratology, or atropine);
- •Typically sleeps at least 7 hours per night.
排除标准
- •Participating in any concurrent clinical or research study;
- •Have astigmatism of more than 1.00 DC in either eye as per non-cycloplegic refraction;
- •Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- •Have any known active* ocular disease and/or infection;
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism, and active allergies;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include antihistamine, atropine eye drops;
- •Have known sensitivity to the sodium fluorescein diagnostic pharmaceutical to be used in the study;
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
- •Are an employee of the Centre for Ocular Research & Education directly involved in this study (i.e. on the delegation log).
研究组 & 干预措施
Lens B
Experimental
干预措施: Lens B (Device)
Lens B
Experimental
干预措施: Lens C (Device)
Lens B
Experimental
干预措施: Lens A (Device)
Lens C
Experimental
干预措施: Lens A (Device)
Lens C
Experimental
干预措施: Lens B (Device)
Lens C
Experimental
干预措施: Lens C (Device)
Lens A
Experimental
干预措施: Lens A (Device)
Lens A
Experimental
干预措施: Lens B (Device)
Lens A
Experimental
干预措施: Lens C (Device)
结局指标
主要结局
Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear
时间窗: After 1 hour of wearing each contact lens
The change in sub-foveal choroidal thickness for the 3 study contact lenses will be compared from baseline to after 1 hour of contact lens wear. Measurements will be conducted on the right eye using a swept-source Optical Coherence Tomographer and measured in micrometers.
次要结局
未报告次要终点
研究者
研究点 (1)
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