A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

• Primary outcome:

• proliferative diabetic retinopathy
• panretinal photocoagulation
• Secondary outcome:

• Vision, Funduscopy, Fundus photograph
• Fundus fluorescein angiography
• Visual Electrophysiology:FERG、OPs、PVEP.
• Optical coherence tomography.
• Symptoms scores of TCM.
• The M0S short-form-36 heaIth survey(SF-36).
• Visual Function Questionnaire-25(VFQ-25).

Inclusion criteria

• Diagnosed with diabetes mellitus.
• Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy
• and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125).
• Diagnosed with the syndrome and signs of TCM.
• HbA1C≤8.0%.
• Ages ranged from 35 to 75 years.
• Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion criteria

• Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.
• The patients who have been received the therapy of Retina laser photocoagulation.
• The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.
• DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.
• Combined with other severe Diabetic complication.
• Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness
• Pregnant or breast feeding.
• combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis.
• Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
• Participated in other clinical trial within 3 month.