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临床试验/NCT06243497
NCT06243497招募中不适用

Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Cytokine profiles(pg/ml)

研究概览

简要总结

Glaucoma is the leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. Ultrasound Cyclo Plasty was first proposed as a new minimally invasive technique in the 1980 s. In recent years, many clinical studies at home and abroad have confirmed the effectiveness, safety and repeatability of UCP. The ciliary body is the target organ of UCP, and the range and accuracy of intraoperative destruction of the ciliary body are the key factors affecting the success or failure of the operation. The production of aqueous humor is closely related to the ciliary body. The dynamic balance of its production and discharge can affect IOP, and its content can directly reflect the intraocular environment. Besides,tears are easy to collect and can be used for follow-up. Previous studies have shown that various proteins in aqueous humor or tear can provide a basis for the pathophysiological changes of glaucoma, and can also be a potential biomarker for predicting the success of anti-glaucoma surgery.

At present, UCP related research focuses on its effectiveness and safety, mainly reflected in three aspects : postoperative intraocular pressure, number of anti-glaucoma drugs and complications, and lack of relevant indicators that directly reflect postoperative intraocular environment changes. The purpose of this study was to reveal the changes of cytokines in aqueous humor after UCP in patients with primary glaucoma, to analyze the possible causes of these factors, and to speculate the effect of their interaction on the surgical effect, in order to increase the predictability of UCP procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The patient was definitely diagnosed as glaucoma, No age or gender limitation, IOP(intraocular pressure) ≥ 21mmHg under the maximum tolerated dose of antiglaucoma medication, or IOP < 21mmHg and glaucomatous optic nerve damage progressed.

排除标准

  • Other eye diseases that could affect IOP; preoperative use of systemic steroid drugs; history of other anti-glaucoma surgery within 3 months; ocular infection 2 weeks prior to UCP

结局指标

主要结局

Cytokine profiles(pg/ml)

时间窗: through study completion, an average of 2 year

Cytokine antibody array was used to detect cytokines in AH samples from UCP treatment group and control group. The analysis method is based on the principle of double antibody sandwich immunoassay, and 60 ul of samples are applied on each block. Antibodies against the selected cytokines were immobilized at specific locations on the chip surface. The cytokines in the sample were captured by the corresponding antibody, and a mixture of biotinylated antibodies was added to detect the binding cytokines. Finally, the signal was visualized using a fluorescent dye ( cy3 equivalent ) that binds to streptavidin. The InnoScan 300 Microarray Scanner ( Innopsys, Parc d 'Activités Activestre, Carbonne, France ) was used for fluorescent dye detection.

Anterior segment parameters(mm)

时间窗: through study completion, an average of 2 year

Measured by ultrasound biomicroscopy, parameters included WTW, ciliary body length, ciliary process length and density.

Intraocular pressure(mmHg)

时间窗: through study completion, an average of 2 year

Using non-contact tonometer (NCT) to measure intraocular pressure

次要结局

  • LogMAR visual acuity(through study completion, an average of 2 year)
  • Complications(n,%)(through study completion, an average of 2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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