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Clinical study of Chufeng Yisun Decoction in the treatment of silicone oil ocular macular edema after vitrectomy

Clinical study of Chufeng Yisun Decoction in the treatment of silicone oil ocular macular edema after vitrectomy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074250
Enrollment
Unknown
Registered
2023-08-02
Start date
2023-03-27
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

Diabetic retinopathy

Interventions

Herbal medicine group:Oral Chufeng Yisun decoction granules
Placebo group:Oral Chinese herbal placebo granules

Sponsors

Eye Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with a diagnosis of type 2 diabetes mellitus; (2) Meet the diagnostic criteria for proliferative diabetic retinopathy, and require 23G vitreous cutting + silicone oil filling surgery; (3) There is macular edema in the eye 1 week after OCT examination, and the measured retinal thickness of the macular area = 300 µm; (4) Be between the ages of 18 and 70; (5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Refractive interstitials are not clear, and it is difficult to observe the fundus; (2) Those with macular slits, glaucoma, retinal vein obstruction, uveitis, optic nerve diseases and other fundus diseases; (3) Patients with severe cardiovascular and cerebrovascular, liver and hematopoietic system diseases and diabetic nephropathy with renal failure; (4) Patients with serious life-threatening primary diseases and mental illnesses; (5) Pregnant or lactating women; (6) Those who are participating in clinical trials of other drugs; (7) The inspection process cannot be cooperated; (8) Can not insist on tracking fundus examination.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity;Optical coherence tomography technology for detecting the thickness of the macular fovea and the area of the macular area;

Secondary

MeasureTime frame
fundus photograph;fluorescence fundus angiography;non-contact intraocular pressure;liver and kidney function;glycosylated hemoglobin;Traditional Chinese Medicine Syndrome Score Scale;

Countries

China

Contacts

Public ContactWu Zhengzheng

Eye Hospital of China Academy of Chinese Medical Sciences

wuzheng202@sina.com+86 133 6669 2366

Outcome results

None listed

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