Diabetic retinopathy
Conditions
Interventions
Idiopathic Epiretinal Membrane (iERM) Group:NA
Healthy Control Group:NA
Non-Proliferative Diabetic Retinopathy (NPDR) Group:NA
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must comprehend the clinical trial and voluntarily participate by providing written informed consent. 2.Aged between 18 and 80 years, inclusive; no restriction on sex. 3.No history or diagnosis of diabetes mellitus. 4.Diabetic Groups: i) Confirmed Diabetes Diagnosis: Diagnosis must meet at least one of the following criteria, accompanied by classic symptoms of diabetes (including polyuria, polydipsia, polyphagia, and unexplained weight loss): Fasting plasma glucose >= 7.0 mmol/L, or 2-hour plasma glucose during an oral glucose tolerance test (OGTT) >= 11.1 mmol/L, or Random plasma glucose >= 11.1 mmol/L, or HbA1c >= 6.5%. *Subjects lacking classic symptoms require either two abnormal glucose values from the same time point or two abnormal glucose values from different time points meeting or exceeding the diagnostic thresholds (e.g., both fasting plasma glucose >=7.0 mmol/L and HbA1c >=6.5% at the same time point; or two separate fasting plasma glucose values >=7.0 mmol/L on different occasions; this criterion excludes random plasma glucose measurements).* Patients with either Type 1 or Type 2 diabetes mellitus will be enrolled. ii) Diabetic Retinopathy (DR) Staging: Based on dilated fundus examination, diabetic subjects will be categorized into: No Diabetic Retinopathy (NDR) Group: History of diabetes but no clinical signs of diabetic retinopathy. Non-Proliferative Diabetic Retinopathy (NPDR) Group: Mild NPDR: Presence of microaneurysms only. Moderate NPDR: Presence of microaneurysms plus other findings less severe than severe NPDR. Severe NPDR: Meeting at least one criterion of the ETDRS "4-2-1 rule": more than 20 intraretinal hemorrhages in each of four quadrants; definite venous beading in two or more quadrants; prominent intraretinal microvascular abnormalities (IRMA) in one or more quadrants. Proliferative Diabetic Retinopathy (PDR) Group: Presence of one or more of the following: neovascularization, vitreous hemorrhage, or preretinal hemorrhage. 5.Idiopathic Epiretinal Membrane (iERM) Group (Control for Vitreous Specimens): This group serves as the control for vitreous specimen collection and analysis from PDR patients.Presence of glistening reflexes or cellophane-like changes over the macula, causing localized retinal wrinkling, with or without distortion of perimacular small vessels. Hyperreflective band on the retinal surface at the macula.Meeting criteria for pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) and epiretinal membrane (ERM) peeling:Best-corrected visual acuity (BCVA) = 0.5 Snellen equivalent but accompanied by progressive vision loss, significant metamorphopsia, diplopia, visual field defects, or other symptoms substantially impacting quality of life, AND surgery is requested by the patient.No history or diagnosis of diabetes mellitus.
Exclusion criteria
Exclusion criteria: 1.Concomitant significant ocular pathologies, including but not limited to glaucoma, age-related macular degeneration (AMD), or uveitis. 2.History of prior ocular surgery. 3.Presence of severe systemic comorbidities (e.g., ischemic heart disease, stroke, malignancy, severe hepatic or renal disease) or history of major systemic surgical procedures (e.g., coronary artery bypass grafting (CABG), arterial/venous thrombolytic therapy, organ transplantation). 4.Cognitive impairment (as indicated by a Mini-Mental State Examination (MMSE) score < 24), diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder), or inability to complete study questionnaires and ophthalmic examinations due to language comprehension deficits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence and progression of diabetic retinopathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity (BCVA);Changes in blood biomarkers;Changes in ocular functional indicators;Changes in ocular structural indicators; | — |
Countries
China
Contacts
Public ContactTao Li
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed