Clinical trial NCT06429969: Metabolomic Profile of Vitreoretinal Diseases: an NMR-Based Approach Using Vitreous.
Official title: Nuclear Magnetic Resonance (NMR)-Based Metabolomic Characterisation of Vitreoretinal Diseases Using Vitreous Fluid
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitreoretinal Disease
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Relative amino acid concentration(Unite: %)
timeFrame: intraoperative
Secondary outcomes:
measure: Relative concentrations of macromolecules such as glucose and lipids(Unite: %)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Eye, Center, Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Lei Du
role: PRINCIPAL_INVESTIGATOR
References: