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A multicenter randomized double-blind controlled study on the staged prevention and treatment of early retinal degeneration in high myopia by combining disease and syndrome

Phase 1
Conditions
Retinal degeneration of high myopia
Registration Number
ITMCTR2200006531
Lead Sponsor
Eye Hospital of China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Diopter = -6.00D and axial length = 26mm
2. Age :20-60
3.HM patient had stage A1 macular lesions and qi and blood deficiency syndrome: if the patient met 1 main symptom +1 secondary symptom, he could be included in the group
4.HM patient had stage A2 macular lesions and qi deficiency and blood stasis syndrome: if the patient met 1 main symptom +1 secondary symptom, he could be included in the group
5. Other vasodilators or neurotrophic drugs are being used and can be included after 1 month of drug withdrawal
6. Informed consent has been signed

Exclusion Criteria

1. Have HM macular cleft, retinal hiatus, neovascularization, retinal detachment, glaucoma and other fundus lesions
2. Accompanied by cardiac, hepatic and renal insufficiency
3. Patients who are participating in clinical trials of other drugs or who are using the same traditional Chinese medicine and other treatments together
4. Patients suffering from hypertension, diabetes and other systemic diseases

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total retinal blood flow density in macular area;
Secondary Outcome Measures
NameTimeMethod
Spherical Equivalent Refraction;Mean retinal thickness in macular area;The thickness of the mGCC;TCM syndrome score;best corrected visual acuity;axial length;Choroid thickness under macular fovea;
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