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Study on the effect of Xiaozhong formula on visual function and vascular changes in diabetic macular edema

Study on the effect of Xiaozhong formula on visual function and vascular changes in diabetic macular edema

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037815
Enrollment
Unknown
Registered
2020-09-02
Start date
2020-09-06
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

diabetic macular edema

Interventions

Sponsors

Eye Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who diagnosed with type 2 diabetes and at least one eye all meet the following criteria; 2. It meets the diagnostic criteria of DME; 3. OCT examination showed macular edema and the retinal thickness in macular area measured =300 µm; 4. The best corrected visual acuity of ETDRS was 78 - 24 letters,which was equivalent to Snellen visual acuity chart 20/32-20/320; 5. The object of syndrome of asdthenic splenonephro-yang and blood stasis obstructs eyes collaterals in TCM; 6. Subjects who sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with unclear refractive stroma and were difficulty in fundus observation; 2. Patients who had been treated by any one or more ways of anti-VEGF or hormone drugs intravitreal injection, grille photocoagulation,local photocoagulation and pan-retinal photocoagulation within 3 months; 3. Patients complicated with glaucoma,retinal vein occlusion,uveitis, optic nerve diseases; 4. Patients complicated with severe cardio-cerebrovascular,liver, hematopoietic system disease and diabetic nephropathy develops renal failure; HBA1c >= 10%,and liver and kidney function more than 1.5 times normal; 5. Patients complicated with severe life-threatening primary disease and psychopath; 6. Pregnancy or lactaing women; 7. Patients who are participating in clinical trials of other drugs; 8. Patients who are unable to cooperate in the examination process and cannot persist in following up the fundus examination.

Design outcomes

Primary

MeasureTime frame
macular area blood flow density;

Secondary

MeasureTime frame
macular area no vascular area;central retina mean thickness;Best corrected visual acuity;Fixation stability;Retinal sensitivity;TCM syndrom score;

Countries

China

Contacts

Public ContactChanhong Jie

Eye Hospital, Chinese Academy of Traditional Chinese Medicine

wangjingying56@163.com+86 13671359790

Outcome results

None listed

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