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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01768260
Other study ID # Eye EECP-1
Secondary ID
Status Recruiting
Phase N/A
First received January 8, 2013
Last updated March 29, 2017
Start date December 2012
Est. completion date March 2018

Study information

Verified date March 2017
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Yan Zhang, MD
Phone 862087755766
Email Zhyan3@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.


Description:

Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- ischemic optic neuropathy

- within 1 month

Exclusion Criteria:

- Hemorrhagic disease

- thrombophlebitis or infection lesions

- severe hypertensive patients

- Atrial fibrillation

- Aortic regurgitation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Enhanced external counterpulsation
EECP is performed for 1 hours every day, for a total of 36 hours.
Drug:
Aspirin
Standard drug therapy

Locations

Country Name City State
China The First Affiliated Hospital of Sun Yat- sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Werner D, Michalk F, Harazny J, Hugo C, Daniel WG, Michelson G. Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina. 2004 Aug;24(4):541-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Central retinal artery flow velocity 7 weeks
Primary visual acuity 7 weeks
Secondary Ophthalmic artery blood flow velocity 7 weeks
See also
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Completed NCT03401892 - Retinal Neuro-vascular Coupling in Patients With Non-arteritic Anterior Ischemic Optic Neuropathy N/A
Terminated NCT00867815 - PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Phase 4
Completed NCT01260324 - Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)