The investigation for the effects of Ti-Luo Hua-Yu Yang-Xue Ming-Mu method on the eyeground blood flow of the NTG patients

Not Applicable

• Conditions: normal tension glaucoma

• Registration Number: ITMCTR1900002799
• Lead Sponsor: China Academy of Chinese Medical Sciences Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual field;optic disc blood flow;Angle of loss of optic nerve fiber layer;vision;upstream blood supply of eye;Thickness of optic nerve fiber layer;