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Effect of EECP on Anterior Ischemic Optic Neuropathy (AION)

This study is currently recruiting participants.
Verified January 2013 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01768260
First received: January 8, 2013
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Anterior Ischemic Optic Neuropathy
 Device: Enhanced external counterpulsation
Drug: Aspirin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy

Resource links provided by NLM:

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

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • visual acuity [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ophthalmic artery blood flow velocity [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Central retinal artery flow velocity [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: aspirin
Active Comparator: aspirin
The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.
 Drug: Aspirin
Standard drug therapy
Other Name: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 8, 2013
Last Updated: January 11, 2013
Health Authority: China: National Natural Science Foundation

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

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013