Study on the effect of Xiaozhong formula on visual function and vascular changes in diabetic macular edema
- Conditions
- diabetic macular edema
- Registration Number
- ITMCTR2000003882
- Lead Sponsor
- Eye Hospital, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who diagnosed with type 2 diabetes and at least one eye all meet the following criteria;
2. It meets the diagnostic criteria of DME;
3. OCT examination showed macular edema and the retinal thickness in macular area measured =300 µm;
4. The best corrected visual acuity of ETDRS was 78 - 24 letters,which was equivalent to Snellen visual acuity chart 20/32-20/320;
5. The object of syndrome of asdthenic splenonephro-yang and blood stasis obstructs eyes collaterals in TCM;
6. Subjects who sign informed consent.
1. Patients with unclear refractive stroma and were difficulty in fundus observation;
2. Patients who had been treated by any one or more ways of anti-VEGF or hormone drugs intravitreal injection, grille photocoagulation,local photocoagulation and pan-retinal photocoagulation within 3 months;
3. Patients complicated with glaucoma,retinal vein occlusion,uveitis, optic nerve diseases;
4. Patients complicated with severe cardio-cerebrovascular,liver, hematopoietic system disease and diabetic nephropathy develops renal failure; HBA1c >= 10%,and liver and kidney function more than 1.5 times normal;
5. Patients complicated with severe life-threatening primary disease and psychopath;
6. Pregnancy or lactaing women;
7. Patients who are participating in clinical trials of other drugs;
8. Patients who are unable to cooperate in the examination process and cannot persist in following up the fundus examination.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method macular area blood flow density;
- Secondary Outcome Measures
Name Time Method Retinal sensitivity;central retina mean thickness;Fixation stability;Best corrected visual acuity;macular area no vascular area;TCM syndrom score;