ITMCTR2100004864招募中4 期
The clinical research of Yiqi Yangyin Huoxue Lishui combined with aflibercept on diabetic macular edema
Chongqing Aier Eye Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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