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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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