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

Vitreoretinal Disease Clinical Trial

— NMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429969
• Other study ID #: WDRY2022-K222
• Status: Recruiting
• Start date: January 17, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Renmin Hospital of Wuhan University
• Contact: Liwei Cheng
• Phone: 027-88041911
• Email: wdrmiit[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2027
• Est. primary completion date: April 17, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Confirmation of IMH diagnosis with concomitant need for PPV surgery;

2. Confirmation of DR diagnosis with concomitant need for PPV surgery;

3. Confirmation of RD diagnosis with concomitant need for PPV surgery;

4. Confirmation of IMM diagnosis with concomitant need for PPV surgery;

5. Confirmation of RVO diagnosis with concomitant need for PPV surgery.

Exclusion Criteria:

1. Diagnosed vitreoretinal disease with no need for PPV surgery;

2. Previous history of PPV surgery;

3. Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;

4. Combination of serious systemic diseases such as hypertension and diabetes mellitus.

Related Conditions & MeSH terms

• Vitreoretinal Disease

Locations

Country	Name	City	State
China	Eye, Center, Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative amino acid concentration(Unite: %)	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.	intraoperative
Secondary	Relative concentrations of macromolecules such as glucose and lipids(Unite: %)	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.	intraoperative