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研究疾病：
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正常眼压性青光眼
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研究疾病代码：
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Target disease：
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normal tension glaucoma
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Target disease code：
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研究类型：
Study type：
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干预性研究
Interventional study
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研究设计：
Study design：
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段：
Study phase：
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其它
Others
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研究目的：
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本研究分两大部分，第一部分即利用光学相干断层扫描血管成像（optical coherence tomography angiography，OCTA）技术检测正常眼压性青光眼(normal-tension glaucoma，NTG)患者视盘血流情况，研究视盘血流与视力、视野、视神经纤维层厚度之间的关系；联合彩色多普勒（color Doppler imaging，CDI）技术评价视盘血流与上游血流供应（包括颈内动脉、眼动脉、视网膜中央动脉系统、睫状后动脉系统）之间的关系，即联合上下游血供的信息探讨血流情况在NTG的发病过程中的作用。第二部分即将“剔络养血明目法”应用于NTG的治疗，利用OCTA、CDI等手段，检测实验组与对照组、及实验组治疗前后视盘血流的变化，同时从视力、视野、视神经纤维层厚度等方面进行“剔络养血明目法”治疗NTG的疗效分析，从功能变化与结构变化两方面证实“剔络养血明目法”的疗效所在。
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Objectives of Study：
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In the first part, optical coherence tomography angiography (OCTA) is used to examine optic disc blood flow in patients with normal tension glaucoma (NTG), and the relationship between optic disc blood flow, the thickness of optic nerve fiber layer and visual field will be studied. And use Color Ddoppler Imaging (CDI) technology to evaluate the relationship between optic disc blood flow and upstream blood supply (including the central retinal artery system of internal carotid artery). In other words, gathering the information of upstream and downstream blood supply to discuss the role of blood flow in the pathogenesis of NTG.
In the second part, to investigate the effects of Tiluohuayu Yangxuemingmu method on the eyeground blood flow of the NTG, using the means OCTA and CDI to test traditional Chinese medicine group and control group before and after the treatment. At the same time, the effects of Tiluohuayu Yangxuemingmu method in the treatment of NTG will be examined by examination of visual field, thickness of optic nerve and vision. So that the effects of Tiluohuayu Yangxuemingmu method on the eyeground blood flow of the NTG will by confirmed in term of functional and structural changes.
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药物成份或治疗方案详述：
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中药组予：“剔络养血明目”，由当归、 土鳖虫川芎黄芪丹参茯苓红花等组成，水煎 红花等组成，水煎 ，常规 剂量， 每日 3次口服 。气滞重者加柴胡、白芍、香附、枳壳等；气虚重者，加党参、白术、桃仁、葛根、三七等。
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Description for medicine or protocol of treatment in detail：
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Traditional Chinese medicine group: Tiluohuayu Yangxuemingmu method. It is composed of Ligusticum wallichii, Angelica sinensis, Astragalus, Ground beeltle and Salviae, safflower and so on, water simmer in water, 3 times service a day of oral. Patients with Qi stagnation add bupleurum root, Radix Paeoniae Alba, Rhizoma Cyperi, and Fructus Aurantii. Patients with Qi deficiency add Radix codonopsis, Bighead atractylodes rhizome, Peach kernel, the root of kudzu vine, Panax notoginseng.
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纳入标准：
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第一部分纳入标准：
正常对照组纳入标准：
1）最佳矫正视力（best corrected visual acuity，BCVA) > 0.8；
2）IOP <21 mmHg；
3）眼底正常，C/D正常，OCT显示RNFL厚度正常，视野正常；
4）年龄在20岁至75岁之间。
HTG组纳入标准：
1）符合西医诊断标准
2）年龄在20岁至75岁之间
NTG组纳入标准：
1）符合西医诊断标准及中医证候标准者；
2）年龄在20岁至75岁之间；
3）局部降眼压药物治疗2个月以上且眼压稳定于15mmHg以下
第二部分纳入标准：
1）符合西医诊断标准及中医证候标准者；
2）年龄在20岁至75岁之间；
3）局部降眼压药物治疗2个月以上且眼压稳定于15mmHg以下
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Inclusion criteria
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Part one inclusion criteria:
Inclusion criteria for Normal control group:
1. the best corrected visual acuity (BCVA) > 0.8;
2. IOP <21 mmHg;
3. The eyeground is normal, C/D is normal. OCT shows normal RNFL thickness and normal visual field;
4. Aged 20 and 75 years.
Inclusion criteria for HTG group:
1. meet the diagnostic criteria;
2. Aged between 20 and 75 years;
Inclusion criteria of NTG group:
1. meet the diagnostic criteria and the TCM Syndrome Diagnostic Criteria;
2. Ages between 20 and 75 years;
3. After lowering intraocular pressure drug therapy, intraocular pressure stabilized below 15mmHg for more than 2 months.
Part two inclusion criteria:
1. meet the diagnostic criteria and the TCM Syndrome Diagnostic Criteria;
2. Ages between 20 and 75 years;
3. After lowering intraocular pressure drug therapy, intraocular pressure stabilized below 15mmHg for more than 2 months.
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排除标准：
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第一部分排除标准：
正常对照组排除标准：
1）青光眼家族史；
2）屈光度大于+3.00D或小于-8.00D；
3）严重系统性疾病如心功能不全，肝肾功能异常，胃、十二指肠溃疡，糖尿病，恶性高血压患者；血清肌酐＞2倍ULN（正常值上限）者；肝功能谷丙转氨酶＞3倍ULN（正常值上限）者；
4）眼部手术史或创伤史；
5）精神类疾病或焦虑、抑郁等异常心理状态；恶性肿瘤患者；
6）妊娠或哺乳期妇女；
7）不能坚持遵医嘱随诊配合相关检查者
NTG、HTG患者组排除标准：
1）固视丢失大于20%；
2）屈光度大于+3.00D或小于-8.00D；
3）Humphrey视野假阳性率或假阴性率大于33%；
4）恶性肿瘤患者；
5）眼部手术史或创伤史；
6）近1个月内因各种原因使用过扩血管、神经保护营养类的中药或西药，预判可能影响试验结果者；
7）对研究药物可疑或明确过敏；
8）血清肌酐＞2倍ULN（正常值上限）者；
9）肝功能谷丙转氨酶＞3倍ULN（正常值上限）者；
10）严重系统性疾病如心功能不全，肝肾功能异常，胃、十二指肠溃疡，糖尿病，恶性高血压患者；
11）以胸闷胸痛，心悸冷汗，恶寒肢冷为主要表现的心阳虚证患者；
12）妊娠或哺乳期妇女；
13）最近3个月参加过其他临床试验；
14）精神类疾病或焦虑、抑郁等异常心理状态；
15）不能坚持遵医嘱随诊配合相关检查及治疗者。
第二部分排除标准：
1）固视丢失大于20%；2）屈光度大于+3.00D或小于-8.00D；3）Humphrey视野假阳性率或假阴性率大于33%；4）恶性肿瘤患者；5）眼部手术史或创伤史；6）近1个月内因各种原因使用过扩血管、神经保护营养类的中药或西药，预判可能影响试验结果者；7）对研究药物可疑或明确过敏；8）血清肌酐＞2倍ULN（正常值上限）者；9）肝功能谷丙转氨酶＞3倍ULN（正常值上限）者；10）严重系统性疾病如心功能不全，肝肾功能异常，胃、十二指肠溃疡，糖尿病，恶性高血压患者；11）以胸闷胸痛，心悸冷汗，恶寒肢冷为主要表现的心阳虚证患者；12）妊娠或哺乳期妇女；13）最近3个月参加过其他临床试验；14）精神类疾病或焦虑、抑郁等异常心理状态；15）不能坚持遵医嘱随诊配合相关检查及治疗者
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Exclusion criteria：
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Part one exclusion criteria:
Exclusion criteria for control group:
1. family history of glaucoma;
2. diopter greater than + 3.00d or less than -8.00d;
3. patients with serious systemic diseases such as heart failure, liver and kidney dysfunctions, gastric and duodenal ulcers, diabetes mellitus and malignant hypertension. Serum creatinine > 2 times upper limit of normal value (ULN); Serum glutamine transaminase > 3 times ULN;
4. History of eye surgery or trauma;
5. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
6. Pregnant or nursing women;
7. Failing to follow doctor's advice and cooperate with relevant examinations.
Exclusion criteria for NTG and HTG group:
1. Fixation loss > 20%;
2. Diopter between + 3.00d and -8.00d;
3. The false-positive or false-negative rate of visual field tested by Humphrey is greater than 33;
4. Patients with malignant tumors;
5. History of eye surgery or trauma;
6. In the past 1 month, have used traditional Chinese medicine or western medicine of vasodilator and neuroprotective drugs;
7. Suspicious or definite allergy to the study drug;
8. Serum creatinine > 2 ULN;
9. Serum glutamine transaminase > 3 ULN;
10. History of eye surgery or trauma;
11. Patients with heart Yang deficiency syndrome are mainly manifested by chest tightness and chest pain, palpitations and cold sweat, and aversion to cold limbs;
12. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
13. Participated in other clinical trials in the last 3 months;
14. Pregnant or nursing women;
15. Failing to follow doctor's advice and cooperate with relevant examinations.
Part two exclusion criteria:
Exclusion criteria for NTG and HTG group:
1. Fixation loss > 20%;
2. Diopter between + 3.00d and -8.00d;
3. The false-positive or false-negative rate of visual field tested by Humphrey is greater than 33;
4. Patients with malignant tumors;
5. History of eye surgery or trauma;
6. In the past 1 month, have used traditional Chinese medicine or western medicine of vasodilator and neuroprotective drugs;
7. Suspicious or definite allergy to the study drug;
8. Serum creatinine > 2 ULN;
9. Serum glutamine transaminase > 3 ULN;
10. History of eye surgery or trauma;
11. Patients with heart Yang deficiency syndrome are mainly manifested by chest tightness and chest pain, palpitations and cold sweat, and aversion to cold limbs;
12. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
13. Participated in other clinical trials in the last 3 months;
14. Pregnant or nursing women;
15. Failing to follow doctor's advice and cooperate with relevant examinations.
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研究实施时间：
Study execute time：
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从From
2019-09-01
至To
2021-05-31
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征募观察对象时间：
Recruiting time：
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从From
2019-12-01
至To
2020-06-02
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