Multimodal Biomarkers in Prediction of Diabetic Retinopathy
NCT ID: NCT07098832
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1538 participants
OBSERVATIONAL
2025-07-31
2030-12-31
Brief Summary
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Participants will be followed up over a 5-year follow-up period, during which they will undergo ophthalmic examinations, blood tests, and questionnaires.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Idiopathic Epiretinal Membrane (iERM) Group
No additional interventions will be performed. Only the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected for control purposes (this will not affect surgical safety or prognosis of the patients).
No interventions assigned to this group
Healthy Control Group
For participants in this group, only anonymous examination data were collected.
No interventions assigned to this group
Proliferative Diabetic Retinopathy (PDR) Group
Disease group, only collect anonymous examination data, and collect the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected (this will not affect surgical safety or prognosis of the patients).
No interventions assigned to this group
Non-Proliferative Diabetic Retinopathy (NPDR) Group
Disease group, for participants in this group, only anonymous examination data were collected.
No interventions assigned to this group
No Diabetic Retinopathy (NDR) Group
For participants in this group, only anonymous examination data were collected.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Aged 18-80 years, with no restriction on gender.
* Healthy control group: No history or diagnosis of diabetes.
* Diabetic group:
i) Definite diagnosis of diabetes. Both type 1 and type 2 diabetic patients will be included in this study.
ii) Based on dilated fundus examination, subjects are classified into NDR, NPDR, and PDR groups according to the staging of diabetic retinopathy.
* Idiopathic epiretinal membrane (iERM) group is set as the control group for intraocular specimen collection and analysis in PDR patients: Funduscopic examination shows gold foil-like reflection or glass membrane-like substance covering the macular area, causing local retinal folds, with or without tortuosity and deformation of small perimacular blood vessels; OCT examination reveals a hyperreflective band on the retinal surface of the macular area; meeting the indications for pars plana vitrectomy combined with internal limiting membrane-epiretinal membrane peeling: visual acuity \< 0.3, or visual acuity \> 0.5 but accompanied by progressive vision loss, severe metamorphopsia, diplopia, visual field defect, or other symptoms that significantly affect quality of life, and surgical treatment can be performed if actively requested by the patient; no diagnosis or history of diabetes.
Exclusion Criteria
* A history of previous ocular surgery.
* Complicated with severe systemic diseases (e.g., ischemic heart disease, stroke, malignant tumor, and severe liver or kidney diseases) or a history of systemic surgery (e.g., coronary artery bypass grafting, arterial/venous thrombolysis, organ transplantation, etc.).
* Complicated with cognitive impairment (MMSE score \< 24), mental illness (e.g., schizophrenia, bipolar disorder), or inability to cooperate with questionnaires and ophthalmic examinations due to language comprehension deficits.
18 Years
80 Years
ALL
Yes
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Principal Investigators
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Li Tao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Clinical Research Center, Zhongshan Ophthalmic Center
Role: primary
Other Identifiers
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2025KYPJ064
Identifier Type: -
Identifier Source: org_study_id
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