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The goal of this observational study is to enroll diabetic patients with diabetic retinopathy and those without diabetic retinopathy, follow up and observe the long-term changes in ocular structure and function of the subjects by comparison, analyze their association with multimodal biomarkers, and explore new methods for the early diagnosis and risk prediction of diabetic retinopathy.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). | ||
| Healthy Control Group | For participants in this group, only anonymous examination data were collected. | ||
| 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). | ||
| Non-Proliferative Diabetic Retinopathy (NPDR) Group | Disease group, for participants in this group, only anonymous examination data were collected. | ||
| No Diabetic Retinopathy (NDR) Group | For participants in this group, only anonymous examination data were collected. |
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| Measure | Description | Time Frame |
|---|---|---|
| The progression of diabetic retinopathy during the follow-up period. | From baseline to study completion, an average of 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best-corrected visual acuity during the follow-up period. | From baseline to study completion, an average of 5 years. | |
| Changes in ocular functional indicators during the follow-up period. | From baseline to study completion, an average of 5 years. |
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Inclusion Criteria:
Participants must understand the clinical trial, voluntarily participate, and sign the informed consent form.
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.
Exclusion Criteria:
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Participants are planned to be enrolled from the outpatient department of Zhongshan Ophthalmic Center, as well as community populations in Guangzhou and surrounding provinces and cities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Tao, MD, PhD | Contact | +86-13724865499 | litao2@mail.sysu.edu.cn | |
| Kangjie Kong, MD, PhD | Contact | +86-15623426876 | kongkj@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Tao, MD, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Blood, vitreous humor, aqueous humor
| Changes in ocular fundus structure during follow-up as indicated by optical coherence tomography (OCT) examination. | From baseline to study completion, an average of 5 years. |
| Changes in ocular fundus blood flow during follow-up by optical coherence as indicated by tomography angiography (OCTA) examination. | From baseline to study completion, an average of 5 years. |
| Blood and intraocular fluid metabolite concentrations measured by metabolomics during follow-up. | From baseline to study completion, an average of 5 years. |
| Blood and intraocular fluid protein concentrations measured by proteomics during follow-up. | From baseline to study completion, an average of 5 years. |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |