Individualized Chinese Medicine for the Treatment of Symptoms Associated with Diabetes-induced Dry Eye Disease: A Single-case Randomized Controlled Trial
Phase 1
- Conditions
- Diabetes-induced Dry Eye Disease
- Registration Number
- ITMCTR1900002461
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. patients with confirmed diabetes-induced Dry Eye Disease;
2. comply with TCM syndrome differentiation standards;
3. aged 18 to 75 years;
4. accepted the survey voluntarily and signed informed consent;
5. ability to return for study visits.
Exclusion Criteria
1. women who were pregnant or breastfeeding;
2. patients with any ocular surface disease, scarring, acute ocular infection, blepharitis, and an unwillingness to discontinue contact lens wear during the study;
3. receive any eye surgery within 3 months;
4. history of diseases that affect vital organs, including heart, liver, and kidney;
5. mental disorder;
6. participated in other clinical trials in recent 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method corneal fluorescein staining;TCM syndrome score;tear film break-up times;tears meniscus height;Ocular Surface Disease Index score;Meibomian gland loss rate;Schirmer tests;
- Secondary Outcome Measures
Name Time Method