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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006531
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-08-23
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal degeneration of high myopia

Interventions

HM macular disease stage A2, treatment group:Oral Yijing Tongluo prescription granules
HM macular disease stage A2, control group:Oral placebo granules
HM macular disease stage A1, control group:Oral placebo granules
HM macular disease stage A1, treatment group:Oral Yijingyangxue prescription granules

Sponsors

Eye Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Total retinal blood flow density in macular area;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactLianrong Yin
yinlrye@126.com13810710448

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026