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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitreoretinal Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Liwei Cheng; Phone Number: 86346 027-88041911; Email: wdrmiit@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Eye, Center, Renmin Hospital of Wuhan University
      • Contact: Liwei Cheng; Phone Number: 86346 02788041911; Email: wdrmiit@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The enrolled participants were patients who attended Renmin Hospital of Wuhan University with a confirmed diagnosis of vitreoretinal disease. As a result, most of the participants were residents of Hubei Province, China. It is expected that vitreous fluid samples collected from patients with IMH, DR, RD, IMM, and RVO were 50, 100, 100, 50, and 50, respectively, for a total of 450, with about a mean age of 56 years.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
IMH group; Participants diagnosed with idiopathic macular hole(IMH) requiring PPV were enrolled in the IMH group, and this group was a control group because the vitreous of IMH may be closest to normal and normal people do not undergo PPV. 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
DR group; In patients with a confirmed diagnosis of diabetic retinopathy (DR) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
RD group; In patients with a confirmed diagnosis of retinal detachment (RD) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
IMM group; In patients with a confirmed diagnosis of idiopathic macular epiretinal membrane (IMM) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.
RVO group; In patients with a confirmed diagnosis of retinal vein occlusion (RVO) and requiring PPV surgery, 100-250ul of vitreous fluid was collected intraoperatively for NMR analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Principal Investigator: Lei Du, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WDRY2022-K222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not considered for the time being, as further processing of the samples are required subsequently and there may be culling data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No