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

NCT06429969 | Recruiting

• 1 other identifier: WDRY2022-K222
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitreoretinal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  intraoperative

Study Arms (5)

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.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Eye, Center, Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The vitreous body is a transparent gel composed mainly of fibrous collagen and hydrophilic hyaluronic acid, with a volume of approximately 4.5 ml, constituting the largest volume in the eye. When patients suffer from vitreoretinal diseases such as IMH, DR, RD, IMM, RVO, PPV is usually required so that it can constitute a passageway to allow instruments to enter the retina for manipulation, at which point the vitreous is disposed of as waste.

Study Officials

• Lei Du

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liwei Cheng

CONTACT

027-88041911; wdrmiit@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)