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临床试验/NCT06429969
NCT06429969招募中不适用

Nuclear Magnetic Resonance (NMR)-Based Metabolomic Characterisation of Vitreoretinal Diseases Using Vitreous Fluid

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年1月17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
450
试验地点
1
主要终点
Relative amino acid concentration(Unite: %)

研究概览

简要总结

The goal of this observational study was to learn about metabolomics profiles in vitreoretinal diseases by nuclear magnetic resonance (NMR)using vitreous fluid. The main question it aimed to answer was abnormal biomarkers for common retinal diseases such as idiopathic macular hole(IMH), diabetic retinopathy(DR) and retinal detachment(RD). Participants would not be subjected to any intervention and the investigators would only collect preoperative information and remaining vitreous samples. The investigators divided the participants into groups with appropriate disease names based on the disease diagnosis, such as IMH group, DR group, and RD group. The MH group was used as a control group, investigators compared other groups to see the metabolomic abnormalities.

详细描述

This study aimed to analyze vitreous fluid using NMR to discover potential biomarkers for the prevention, early diagnosis, and treatment of vitreoretinal diseases and to reveal the mechanisms of disease progression. Patients suffering from IMH, DR, RD, idiopathic macular epiretinal membrane (IMM), and retinal vein occlusion (RVO) quiring for pars plana vitrectomy (PPV), who visited Renmin Hospital of Wuhan University, were chosen to participate in this study. Participants were not subjected to any intervention and the investigator only collected preoperative information and remaining vitreous samples. Participants provided preoperative examination information and medical history, and the investigators divided the participants into five groups with corresponding disease names based on the disease diagnosis, including five groups for five diseases: IMH group, DR group, RD group, IMM group, and RVO group. The control group for the diseases was the IMH group, and metabolomic differences were observed. These patients are usually treated with PPV, during PPV typically performed on these patients, vitreous fluid is usually disposed of as waste, and investigators collected 100-250 ul of the fluid for NMR analysis to see metabolomic characterization of these diseases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmation of IMH diagnosis with concomitant need for PPV surgery;
  • Confirmation of DR diagnosis with concomitant need for PPV surgery;
  • Confirmation of RD diagnosis with concomitant need for PPV surgery;
  • Confirmation of IMM diagnosis with concomitant need for PPV surgery;
  • Confirmation of RVO diagnosis with concomitant need for PPV surgery.

排除标准

  • Diagnosed vitreoretinal disease with no need for PPV surgery;
  • Previous history of PPV surgery;
  • Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;
  • Combination of serious systemic diseases such as hypertension and diabetes mellitus.

结局指标

主要结局

Relative amino acid concentration(Unite: %)

时间窗: intraoperative

NMR provides spectral data to show the relative concentration of various amino acids, and the use of NMR to measure vitreous humor and compare changes in amino acid content across disease species leads to speculation about biological markers of disease progression.

次要结局

  • Relative concentrations of macromolecules such as glucose and lipids(Unite: %)(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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