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Effect of EECP on Anterior Ischemic Optic Neuropathy (AION)

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ClinicalTrials.gov Identifier: NCT01768260
Recruitment Status : Recruiting
First Posted : January 15, 2013
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Condition or disease Intervention/treatment
Anterior Ischemic Optic Neuropathy Device: Enhanced external counterpulsation Drug: Aspirin

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy
Study Start Date : December 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Enhanced External conterpulsation
Enhanced external counterpulsation (EECP) is a noninvasive modality for the treatment of ischemic cardiovascular disease. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole.
Device: Enhanced external counterpulsation
EECP is performed for 1 hours every day, for a total of 36 hours.
Other Name: EECP
Drug: Aspirin
Standard drug therapy
Active Comparator: aspirin
The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.
Drug: Aspirin
Standard drug therapy



Primary Outcome Measures :
  1. visual acuity [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Ophthalmic artery blood flow velocity [ Time Frame: 7 weeks ]

Other Outcome Measures:
  1. Central retinal artery flow velocity [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ischemic optic neuropathy
  • within 1 month

Exclusion Criteria:

  • Hemorrhagic disease
  • thrombophlebitis or infection lesions
  • severe hypertensive patients
  • Atrial fibrillation
  • Aortic regurgitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768260


Contacts
Contact: Yan Zhang, MD 862087755766 ext 8141 Zhyan3@mail.sysu.edu.cn

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat- sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ling Zhang, MA    862087755766 ext 8035    Zhanglingaben@126.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Yan Zhang, Professor First Affiliated Hospital of Sun Yat-sen University

Publications:
Responsible Party: WenHui Zhu, Oculist-in-charge, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01768260     History of Changes
Other Study ID Numbers: Eye EECP-1
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University:
visual acuity
artery flow velocity
Enhanced External Counterpulsation
Ischemic
Optic Neuropathy

Additional relevant MeSH terms:
Ischemia
Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics