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    【ChiCTR1900021995】Retinal Nerve Fiber Layer Optical Texture Signature as a Novel Biomarker for Detection of Glaucoma Progression

    基本信息
    登记号

    ChiCTR1900021995

    试验状态

    正在进行

    药物名称

    /

    药物类型

    /

    规范名称

    /

    首次公示信息日的期

    2019-03-19

    临床申请受理号

    /

    靶点

    /

    适应症

    青光眼

    试验通俗题目

    Retinal Nerve Fiber Layer Optical Texture Signature as a Novel Biomarker for Detection of Glaucoma Progression

    试验专业题目

    Retinal Nerve Fiber Layer Optical Texture Signature as a Novel Biomarker for Detection of Glaucoma Progression

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    1. To compare the hazard ratios for development of visual field progression upon detection of progressive decline in retinal nerve fiber layer (RNFL) optical texture signature versus upon detection of progressive RNFL thinning 2. To compare the survival distributions between eyes with progressive RNFL thinning and eyes with progressive decline in RNFL optical texture signature 3. To determine the specificities of Trend-based Progression Analysis (TPA) for detection of progressive decline in RNFL optical texture signature and progressive RNFL thinning 4. To measure rates of change of VF mean deviation between eyes with and without progressive decline in RNFL thickness/optical texture signature 5. To measure age-related rates of change of RNFL thickness/optical texture signature 6. To compare the sensitivity and specificity for detection of glaucoma between ROTA and conventional OCT analysis

    试验分类
    试验类型

    析因分组（即根据危险因素或暴露因素分组）

    试验分期

    其它

    随机化

    N/A

    盲法

    N/A

    试验项目经费来源

    General Research Fund 2018-19

    试验范围

    /

    目标入组人数

    539

    实际入组人数

    /

    第一例入组时间

    2019-04-01

    试验终止时间

    2023-06-30

    是否属于一致性

    /

    入选标准

    The inclusion criteria are: age ≥18 years; best corrected visual acuity (VA) ≥20/40.；

    排除标准

    The exclusion criteria are: IOP >30mmHg; only one eye with functional vision; inability to perform reliable VF; pathological myopia (eyes with axial length≥26mm with lacquer cracks and chorioretinal atrophy); suboptimal quality of OCT images; previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/ maculopathy.；

    研究者信息
    研究负责人姓名
    试验机构

    Research Grant Council, University Grants Committee

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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