JPRN-jRCTs032230425招募中2 期
Exploratory clinical study for early detection of glaucoma using novel evaluation device. - Exploratory clinical study for early detection of glaucoma using novel evaluation device.
Akiba Ryutaro0 个研究点目标入组 39 人开始时间: 2023年10月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •[Healthy subject]
- •Subject meeting all of below conditions:
- •1. Age between 20 and 80 years.
- •2. Eyes with open angle
- •3. Eyes with best corrected decimal visual acuity of or above 0.5
- •4. Eyes with refractive error of less than -6 diopters (spherical) and -3 diopters (cylinder).
- •5. Subject must undergo through explanation of the study, then sign the written consent form upon subject's free will.
- •6. Eyes without diagnosis of glaucoma or preperimetric glaucoma.
- •[Glaucoma subject]
- •Must meet criteria 1-5 of healthy subjects, and have eyes diagnosed as glaucoma.
- •[Preprimetric glaucoma subject]
- •Must meet criteria 1-5 of healyh subjects, and have eyesdiagnosed as preperimetric glaucoma.
排除标准
- •1. Subject regarded as non-qualified by doctor in chief of the clinical study.
- •2. Eyes with history of ocular trauma, or intraocular surgery (Except for cataract and glaucoma with no surgical complications.)
- •3. Eyes with underlying retinal disease, uveitis, and non-glaucomatous optic neuritis.
- •4. History of optic chiasm disaese or demyelinating disease that affect visual field.
- •5. History of cognitive disase including Parkinson's diesase, Alzheimer's disease, and cerebral infarction.
- •6. Eyes with poor fixation upon Humphrey visual field test.
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