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

NCT ID: NCT06429969

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Vitreoretinal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Du

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

Eye, Center, Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liwei Cheng

Role: CONTACT

wdrmiit@163.com

027-88041911 ext. 86346

Facility Contacts

Liwei Cheng

Role: primary

wdrmiit@163.com

02788041911 ext. 86346

Other Identifiers

WDRY2022-K222

Identifier Type: -

Identifier Source: org_study_id