Diabetic macular edema
Conditions
Interventions
Control group:No use of traditional Chinese medicine.
Combined treatment group:Oral administration of Chinese patent medicine.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated hospital of Guangzhou University of Chinese medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 - 85 years old regardless of gender. (2) Meeting the diagnostic criteria for type 2 diabetes mellitus (DM). (3) Patients who have been clearly diagnosed with diabetic retinopathy (DR) through fundus fluorescein angiography (FFA). (4) Central macular thickness (CMT) > 250µm. (5) The time interval between the last DME - related treatment and the current anti - VEGF treatment is more than 3 months. (6) Patients who are diagnosed as having the syndrome type of qi - yin deficiency and phlegm - blood stasis inter - obstruction through traditional Chinese medicine four - diagnostic methods.
Exclusion criteria
Exclusion criteria: (1) Patients with refractive media opacity affecting fundus observation. (2) Patients accompanied by diseases such as glaucoma and optic nerve ischemia that affect the patient's vision or fundus. (3) Patients with macular edema not caused by DM such as retinal vein occlusion and wet age - related macular degeneration. (4) Patients with severe diabetes uncontrollable blood sugar combined with diabetic ketoacidosis or hyperosmolar coma. (5) Patients receiving hemodialysis treatment and other treatments that lead to unstable biochemical indicators. (6) Patients with impaired liver and kidney function (Crea is higher than 1.5 times the upper limit of the normal value of the Clinical Laboratory of Guangdong Provincial Hospital of Traditional Chinese Medicine and ALT and AST are higher than 2 times the upper limit of the normal value of the Clinical Laboratory of Guangdong Provincial Hospital of Traditional Chinese Medicine). (7) Pregnant and lactating women. (8) Patients allergic to any component of anti - VEGF drugs those with active or suspected peri - ocular and intra - ocular infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity;Interleukin-1ß;TNF-a; | — |
Secondary
| Measure | Time frame |
|---|---|
| Superficial capillary plexus vessel density;Disorganization of the Retinal Outer Layers;Foveal Avascular Zone;Central macular thickness;Disorganization of the Retinal Inner Layers;hyperreflective foci;Deep capillary plexus vessel density; | — |
Countries
China
Contacts
Public ContactLu Wang
Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated hospital of Guangzhou University of Chinese medicine)
Outcome results
None listed