Diabetic retinopathy
Conditions
Interventions
Test group:On the basis of the original hypoglycemic plan, lutein gluconate zinc vitamin A soft capsules were added, 5 capsules each time, 2 times a day, with a daily intake of 48mg lutein. They were
control group:On the basis of the original hypoglycemic regimen, placebo (zinc gluconate vitamin A soft capsules) was added, 5 capsules each time, twice a day, orally for 6 months, and corresponding i
Sponsors
Sun Yat sen Memorial Hospital of Sun Yat sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The patient voluntarily participates in the trial and has the ability to sign an informed consent form; (2) Age greater than 18 years old and less than 75 years old; (3) Diagnosed as type 2 diabetes, the existing hypoglycemic program has been used for >=3 months, and after using the existing hypoglycemic program, HbA1c <=8.0%, Patients with FPG<7.5 mmol/L and 2hPG<11.1 mmol/L. (4) Patients diagnosed with no DR or mild to moderate NPDR through optical coherence angiography (OCTA), visual acuity examination, dilated pupil fundus examination, and if necessary, fluorescein angiography.
Exclusion criteria
Exclusion criteria: (1) Patients with persistent hyperglycemia with HbAlc>8.0%; (2) Patients after retinal photocoagulation, patients suitable for photocoagulation, and patients with one or two eyes of diabetes retinopathy in proliferative phase; (3) Type I diabetes patients with diabetes retinopathy; (4) Those with other eye diseases (such as glaucoma, cataract that significantly affects fundus examination, non diabetes retinopathy, uveitis, retinal detachment, optic neuropathy and high myopia with fundus diseases); (5) Patients with severe primary diseases such as cardiovascular, liver, kidney, and hematopoietic systems, with serum transaminase levels greater than 1.5 times normal, and those with mental illness; (6) Renal failure occurs in diabetes nephropathy (azotemia stage, uremia stage); (7) Pregnant, pregnant or breastfeeding women, or those with a history of drug allergies; (8) Participants in clinical trials of other drugs within the past three months; (9) Those who have used drugs to treat diabetes retinopathy in the past week; (10) Systolic blood pressure>160 mmHg or diastolic blood pressure>100 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Record the changes in retinal capillary density values in the macular area of the patient compared to baseline after 6 months of treatment (6 × 6 mm OCTA); | — |
Secondary
| Measure | Time frame |
|---|---|
| After 6 months of treatment (6×6 mm OCTA), the changes of retinal thickness in the macular area and the area of the foveal avascular area were recorded from baseline;After 6 months of treatment, the change in best corrected visual acuity (BCVA) from baseline was recorded (ETDRS eye chart).;After 6 months of treatment, the Ocular Surface Disease Index (OSDI) was used to evaluate the dry eye grade of patients before and after treatment; | — |
Countries
China
Contacts
Public ContactLan Yuqing
Sun Yat sen Memorial Hospital of Sun Yat sen University
Outcome results
None listed