jRCT2032260290招募中不适用
A clinical study to confirm the efficacy and safety of hard contact lenses for vision correction (SS-200)
未提供0 个研究点目标入组 30 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects with corneal astigmatism in the target eye who cannot achieve a decimal visual acuity of 0.7 or higher with glasses or existing soft contact lenses and who have difficulty in using existing hard contact lenses due to a foreign body sensation, eye pain, or displacement or fallout of the lens
- •Subjects whose best-corrected visual acuity with glasses in the target eye at the initial visit is a decimal visual acuity of 0.01 or higher
- •Subjects who are judged to be eligible for wearing contact lenses in the opinion of the investigator or the subinvestigator
- •Subjects aged 18 years or older who understood the purpose of the study and voluntarily signed the consent form
- •Subjects who are able to undergo routine medical examinations and follow the instructions and directions of the investigator or the subinvestigator
排除标准
- •Subjects who have worn scleral lenses
- •Subjects who have a history of allergy after using existing soft contact lenses, existing hard contact lenses, or contact lens care products
- •Subjects who have turbidity, etc., in the visual field due to corneal stromal opacity, etc., and for whom the effect of vision correction by contact lenses, etc., cannot be expected in the opinion of the investigator or the subinvestigator
- •Subjects who currently require glaucoma treatment such as eye drops
- •Subjects who are judged to be inappropriate for wearing contact lenses in the opinion of the investigator or the subinvestigator due to ongoing treatment (e.g., eye drops), etc., after corneal surgery
- •Subjects who have acute or subacute inflammation in the anterior segment of the eye (e.g., bacterial, fungal, or viral keratitis, autoimmune corneal ulcer, conjunctivitis, and scleritis)
- •Subjects who have infection in the anterior segment of the eye (e.g., eyelid infection, conjunctival infection, and corneal infection)
- •Subjects who have uveitis (iritis, uveitis other than that in the iris)
- •Subjects with any retinal disease
- •Subjects with a damaged surface in the anterior segment of the eye
- •Subjects with cataracts that may affect visual acuity
- •Subjects with progressive keratoconus
- •Subjects in whom intraocular pressure exceeds the value specified in the protocol at the initial visit
- •Subjects in whom the corneal endothelial cell count is below the value specified in the protocol at the initial visit
- •Subjects with decreased corneal sensation
- •Subjects with eyelid abnormality
- •Subjects with serious lacrimal fluid abnormality
- •Other subjects who meet the exclusion criteria specified in the protocol
研究者
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