Diabetic Retinopathy Clinical Trial
Official title:
A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic
Retinopathy.
2. Objectives of study: To evaluate the Intervention effect of integrate control protocol
on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then
produce a high performance, optimize, convenient, applicable and demonstrated protocol
of integrate control with Intervention of TCM and west medicine.
3. Study Type: Interventional
4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes
Assessor), Parallel Assignment, Positive controlled clinical study.
5. Sample size: 480 subjects , divided into test and control groups equally.
6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal
photocoagulation
1. Primary outcome:
- proliferative diabetic retinopathy
- panretinal photocoagulation
2. Secondary outcome:
- Vision, Funduscopy, Fundus photograph
- Fundus fluorescein angiography
- Visual Electrophysiology:FERG、OPs、PVEP.
- Optical coherence tomography.
- Symptoms scores of TCM.
- The M0S short-form-36 heaIth survey(SF-36).
- Visual Function Questionnaire-25(VFQ-25).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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