Eye-acupuncture therapy combined with visual rehabilitation in low-vision patients with severe diabetic macular edema: a randomised controlled trial
- Conditions
- diabetic macular edema
- Registration Number
- ITMCTR2000003917
- 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. The patients with severe DME diagnosed as hard exudation involving macular center, aged 40-75 years;
2. According to DR diagnosis (the ophthalmology group of Ophthalmology branch of Chinese Medical Association formulated the guidelines for clinical diagnosis and treatment of diabetic retinopathy in China (2014));
3. If the visual acuity was between 0.05-0.3 (20 / 400-20 / 64), and both eyes met the standard, the eyes with better vision were selected;
4. OCT showed that the macular retinal thickness was less than 300 µ m and stable for at least half a year;
5. TCM syndrome differentiation is spleen kidney yang deficiency syndrome;
6. Signed informed consent.
1. The refractive stroma is not clear and it is difficult to observe the fundus;
2. Patients with glaucoma, retinal vein occlusion, uveitis, optic nerve disease and other eye diseases;
3. Patients with severe cardiovascular and cerebrovascular diseases, liver and hematopoietic system diseases;
4. Patients with a history of serious life-threatening primary diseases, neurological and mental diseases;
5. Participants in other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method best corrected visual acuity;macular retinal sensitivity;Reading speed;
- Secondary Outcome Measures
Name Time Method Fixation stability;