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Eye-acupuncture therapy combined with visual rehabilitation in low-vision patients with severe diabetic macular edema: a randomised controlled trial

Eye-acupuncture therapy combined with visual rehabilitation in low-vision patients with severe diabetic macular edema: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003917
Enrollment
Unknown
Registered
2020-09-09
Start date
2020-09-30
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

diabetic macular edema

Interventions

Sponsors

Eye Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients with severe DME diagnosed as hard exudation involving macular center, aged 40-75 years; 2. According to DR diagnosis (the ophthalmology group of Ophthalmology branch of Chinese Medical Association formulated the guidelines for clinical diagnosis and treatment of diabetic retinopathy in China (2014)); 3. If the visual acuity was between 0.05-0.3 (20 / 400-20 / 64), and both eyes met the standard, the eyes with better vision were selected; 4. OCT showed that the macular retinal thickness was less than 300 µ m and stable for at least half a year; 5. TCM syndrome differentiation is spleen kidney yang deficiency syndrome; 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The refractive stroma is not clear and it is difficult to observe the fundus; 2. Patients with glaucoma, retinal vein occlusion, uveitis, optic nerve disease and other eye diseases; 3. Patients with severe cardiovascular and cerebrovascular diseases, liver and hematopoietic system diseases; 4. Patients with a history of serious life-threatening primary diseases, neurological and mental diseases; 5. Participants in other clinical trials.

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity;macular retinal sensitivity;Reading speed;

Secondary

MeasureTime frame
Fixation stability;

Countries

China

Contacts

Public ContactWang Jianwei

Eye Hospital, Chinese Academy of Traditional Chinese Medicine

wjwfmmu@126.com+86 13381150382

Outcome results

None listed

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