The clinical research of Yiqi Yangyin Huoxue Lishui combined with aflibercept on diabetic macular edema
- Conditions
- diabetic macular edema
- Registration Number
- ITMCTR2100004864
- Lead Sponsor
- Chongqing Aier Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Western medicine diagnostic criteria are made according to the diagnostic criteria of clinically significant macular edema recommended by and the Early Treatment Diabetic Retinopathy Study (ETDRS) in the United States:
1.Having a clear history of diabetes;
2.Macular edema or associated with the following lesions, including microangioma, retinal hemorrhage, hard exudation, and cotton spots, were observed under ophthoscope;
3.There was retinal thickening in the area of 500um in the macular center, OCT showed macular thickness > 250um, and FFA showed luciferin leakage in the macular area;
4.At the same time, according to the standard of macular edema recommended by ETDRS, the classification was carried out.
(1)Local edema: FFA showed that lucilucin leakage mainly came from single or cluster microhemangiomas in macular area, or from a small segment of dilated capillaries, and late leakage only occupied local area of macular area;
(2)Diffuse edema type: FFA showed luciferin leakage from retinal and/or choroidal capillaries, forming extensive luciferin leakage, occupying the whole macular area;
(3)Macular cystic edema type: FFA showed that late macular formation of petal-like and/or beehive-like fluorescein leakage, often accompanied by diffuse macular edema, can also occur alone, statistically classified as diffuse edema type.
TCM diagnostic criteria refer to the standard of Qi and Yin deficiency syndrome in : visual faintness, retinal macular edema, retinal bleeding and exudation can be seen in the fundus of the disease; Complexion, God tired little gas, dry pharynx, five upset hot; Light tongue, weak or astringent pulse.
1.Conform to the above-mentioned western and traditional Chinese medicine diagnostic criteria;
2.Control of blood glucose and blood pressure, HbA1c < 8.3%, fasting blood glucose. 8.3mmol/L, 2h postprandial blood glucose < 11.1mmol/L, blood pressure < 150/90 mmHg.
3.To complete treatment and follow-up for at least 5 months;
4.All patients were informed of the study and signed the consent form.
1.Systemic patients with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, or blood diseases;
2.Allergic to sodium fluorescein;
3.Pregnant or lactating women;
4.Psychopaths.
5.Local retinal pulling or detachment of the eye;
6.After the operation, the vitreous cavity was filled with gas or silicone oil.
7.History of vitreoretinal surgery;
8.DME secondary to non-diabetic retinopathy;
9.The opacity of the refractive interstitium affects the observer.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean retinal thickness and blood flow in the macular fovea with a diameter of 1mm;Best corrected visual acuity;
- Secondary Outcome Measures
Name Time Method Determination of drug concentration of abercep in vitreous body fluids;The expression of HIF-1a, TNF-a, SICAM-1 and VEGF in vitreous body fluids were detected;Fundus camera;Multifocal electroretinograms;