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Recruiting NCT06429969

Metabolomic Profile of Vitreoretinal Diseases: an NMR-Based Approach Using Vitreous.

— Observational Vitreoretinal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vitreoretinal Disease. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Relative amino acid concentration(Unite: %) [Time frame: intraoperative]
Secondary outcome measures (1)
  • Relative concentrations of macromolecules such as glucose and lipids(Unite: %) [Time frame: intraoperative]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Eye, Center, Renmin Hospital of Wuhan University — Wuhan

Identifiers

NCT: NCT06429969 · WDRY2022-K222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗