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NCT Number: NCT06429969

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye, Center, Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location status: Recruiting

Location contact

Liwei Cheng

CONTACT

[email protected]

02788041911 ext. 86346

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Relative amino acid concentration(Unite: %)

    Time frame: 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.

Secondary outcomes

  1. Relative concentrations of macromolecules such as glucose and lipids(Unite: %)

    Time frame: intraoperative

    Macromolecules such as glucose and lipids also play a role in the metabolism of vitreoretinal diseases, so NMR spectroscopy will be used to show the relative concentration of macromolecules.

Study contacts

Contact information is provided by the study sponsor or research team.

Liwei Cheng

CONTACT

[email protected]

027-88041911 ext. 86346

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

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

Acronym: NMR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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