glaucoma
Conditions
Interventions
Chinese herbal granules+acupuncture group:Tiluo Yangxue Granules for oral administration,acupuncture treatmentt
Chinese herbal simulated granules+acupuncture waiting group:Tiluo Yangxue simulated Granules for oral administration,acupuncture treatment later
Chinese herbal simulated granules+acupuncture Group:Tiluo Yangxue simulated Granules for oral administration,acupuncture treatment
Chinese herbal granules+acupuncture waiting group:Tiluo Yangxue Granules for oral administration,acupuncture treatment later
Sponsors
Eye Hospital of China Academy of CMS
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) After a comprehensive ophthalmic examination it meets the diagnostic criteria for POAG; (2) Traditional Chinese medicine syndrome differentiation is characterized by deficiency of qi and blood and subtle meridians and collaterals; (3) 18 years old = age = 70 years old; (4) Study on the effect of topical intraocular pressure lowering medication for 1 month/6 months after selective laser trabeculoplasty and anti glaucoma surgery/without medication with a peak intraocular pressure of 10mmHg = 24 hours = 21mmHg (measured by Goldman tonometer 24-hour intraocular pressure curve). Stable treatment plan for more than 3 weeks before inclusion; (5) Study the best corrected visual acuity of the eyes = 20/200 (ETDRS visual acuity chart); (6) Study the Humphrey visual field (modified H-P-A visual field staging) as early middle and advanced stages; (7) Subjects who were taking drugs to improve circulation and nutrition or similar traditional Chinese medicine decoction granule traditional Chinese patent medicines and simple preparations before inclusion can be included in this trial after a 4-week wash out period. Subjects who were receiving Bromonidine Tartrate eye drops before inclusion and had a 2-week washout period can be included in this trial. Subjects who were receiving acupuncture and moxibustion ear point pressing pills and the same type of treatment before inclusion can be included in this trial after 2 weeks of cessation; (8) Informed consent and signing of informed consent. Note: Each participant will be studied on one eye with the more severely affected side as the study eye. For those with the same severity in both eyes the right eye will be used as the study eye. The contralateral eye received the same treatment and was not included in the clinical study.
Exclusion criteria
Exclusion criteria: (1) To study the clinical significance of cornea iris obvious lens diseases and various fundus diseases optic neuropathy in the eyes such as keratitis uveitis glaucoma and ciliary syndrome retinal detachment retinal arteriovenous occlusion retinitis pigmentosa diabetes retinopathy ischemic optic neuropathy etc; (2) History of severe dry eye syndrome; (3) The refractive interstitium is significantly turbid which is judged by the researchers to affect vision visual field and other examinations (mild turbidity which is judged by the researchers to not affect vision visual field and other examinations can still be included in the experiment); (4) Individuals with one eye or eye deformities; (5) Those who cannot accept the use of a flat tonometer for measurement (such as obvious abnormalities on the corneal surface corneal scars keratoconus etc.); (6) Those who must wear contact lenses (such as contact lenses or contact lenses) during the trial period; (7) Any active or recurrent intraocular infection or inflammation in any eye within the past 3 months; (8) Study individuals who have undergone any intraocular surgery within the past 6 months; (9) Study individuals who have experienced eye trauma within the past 6 months; (10) Those who need to use drugs that improve circulation and nourish nerves and those who cannot stop using them in the short term; (11) Those who plan to undergo any eye surgery or laser treatment; (12) Individuals with intellectual or cognitive impairments or mental illnesses who are unable to provide sufficient informed consent (excluding those with mild anxiety or depression); (13) The screening test results meet any of the following criteria: 1) Untreated or poorly controlled hypertension: systolic blood pressure (SBP) = 160mmHg and/or diastolic blood pressure (DBP) = 100 mmHg; 2) Untreated or poorly controlled diabetes; 3) Untreated or uncontrolled hypothyroidism/hyperthyroidism; 4) Significant abnormal liver function: ALT/AST = 1.5 times the upper limit of normal value; 5) Significant abnormalities in renal function: creatinine above the upper limit of normal; 5) Coagulation dysfunction; 6) Patients with severe heart and lung dysfunction severe arrhythmia (rapid atrial fibrillation atrial flutter paroxysmal ventricular tachycardia third degree atrioventricular block etc.); 7) Patients with advanced tumors or other severe or progressive systemic diseases. (14) Those who are currently participating in clinical trials of other drugs or have participated in clinical trials of similar drugs within the past 3 months; (15) Positive pregnancy test pregnant or lactating women and those planning to conceive; (16) Suspected or with a history of alcohol or drug abuse; (17) Individuals who are allergic to three or more drugs or foods or known to be allergic to traditional Chinese medicine granules and their components; (18) Researchers believe that individuals who are not suitable to participate in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in mean defect (MD) of visual field from baseline the end of 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in mean defect (MD) of visual field from baseline at 2 weeks of treatment;The Changes in Traditional Chinese Medicine Syndrome Quantification Scale Scores from Baseline at Weekends 2 and 4 of Treatment;The changes in best corrected visual acuity (BCVA) compared to baseline during the 2nd and 4th weekend of treatment;The changes in the pattern standard deviation (PSD) of the visual field at 2 and 4 weeks of treatment compared with the baseline;The Changes in Quality of Life Scale (Glau-QoL17) scores of glaucoma patients after 2 and 4 weeks of treatment compared to baseline; | — |
Countries
China
Contacts
Public ContactLi Xin
Eye Hospital of China Academy of CMS
Outcome results
None listed