Actively Recruiting
Study of Natural Course Progression of Diabetic Retinopathy
Led by Jie Li · Updated on 2024-03-12
200
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy. Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition. The contents of follow-up examinations are: History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure. Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition). Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol. Urinary microalbumin/urinary creatinine ACR. Microvisual field.
CONDITIONS
Official Title
Study of Natural Course Progression of Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with type 2 diabetes aged 18 to 75 years
- Able to cooperate with examinations and sign informed consent
- No other eye diseases causing retinal neovascularization
- No significant media haze affecting fundus image quality
- No history of fundus laser treatment or no laser treatment expected within 6 months
- No previous intravitreal drug injections and none expected in the next 6 months
- Macular thickness within specified limits (Zeiss OCT women < 290µm, men < 305µm; Heidelberg OCT women < 305µm, men < 320µm)
- Diabetic retinopathy lesions less severe than non-proliferative diabetic retinopathy (NPDR) on clinical mydriasis and Optos 7 field imaging
- No history of eye surgery
You will not qualify if you...
- Patients with kidney failure
- History of systemic anti-VEGF therapy within the last month
- Follow-up expected to be difficult or patients with traction retinal detachment from other provinces
- History of allergy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sichuan Academy of Medical Science Sichuan Provincial Hosptial
Chengdu, Sichuan, China, 610014
Actively Recruiting
Research Team
J
Jie Li, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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