Type 2 diabetes with non-proliferative diabetic retinopathy and/or nerve injury without fundus abnormalities Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
The participants are randomized 1:1 into two groups. The random number sequence is generated using the PROC PLAN command in SAS 9.4 (SAS Institute, Cary, NC, USA) and enclosed in opaque anonymous enve
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years 2. Diagnosed with type 2 diabetes mellitus according to the World Health Organization (WHO) 1999 diagnostic criteria 3. Diagnosed with nonproliferative diabetic retinopathy (NPDR) according to the 2002 International Clinical Diabetic Retinopathy Disease Severity Scale 4. Nerve injury was confirmed by electroretinogram (ERG) 5. Corrected visual acuity =0.8 6. Received stable hypoglycemic drug therapy for =3 months
Exclusion criteria
Exclusion criteria: 1. Other non-diabetic ocular diseases that might interfere with the results of fundus examination (such as glaucoma, cataract, non-diabetic hemorrhagic eye disease, uveitis, retinal detachment, optic nerve disease, ocular refractive interstitial abnormalities, etc) 2. Proliferative diabetic retinopathy (PDR) 3. HbA1c >8.0% 4. Diabetic retinopathy (DR) caused by type 1 or special types of diabetes 5. Intraocular surgery within 6 months, 6) central nervous system diseases 7. Allergic diseases or allergic to the study drugs 8. Participated in clinical trials within the past 3 months 9. Used drugs for the treatment of DR within the past 3 months 10. Severe systemic diseases, malignant tumors, mental illnesses, or others that might interfere with the results of this study 11. Could not take medicines as planned, or unwilling or unable to perform regular follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal nerve fiber layer (RNFL) thickness and foveal avascular zone (FAZ) area measured using optical coherence tomography angiography (OCTA) at baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Retinal nerve fiber layer (RNFL) thickness and foveal avascular zone (FAZ) area are measured using the optical coherence tomography angiography (OCTA) at baseline and 12 weeks 2. The proportion of abnormal full-field electroretinogram (ERG) results measured using full-field ERG at baseline, 12 and 24 weeks 3. The proportion of abnormal dilated fundus examination results measured using fundoscopy at baseline, 12 and 24 weeks 4. The proportion of abnormal visual acuity measured using visual chart and comprehensive optometry at baseline,12 and 24 weeks 5. Quality of life measured using the visual function questionnaire (NEI-VFQ-25), the health survey questionnaire (SF-36 scale) and the scores of traditional Chinese medicine (TCM) syndrome element scale at baseline, 12 and 24 weeks | — |
Countries
China
Outcome results
None listed