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Effect of EECP on Anterior Ischemic Optic Neuropathy (AION)

Primary Purpose

Anterior Ischemic Optic Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced external counterpulsation
Aspirin
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Ischemic Optic Neuropathy focused on measuring visual acuity, artery flow velocity, Enhanced External Counterpulsation, Ischemic, Optic Neuropathy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ischemic optic neuropathy
  • within 1 month

Exclusion Criteria:

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat- sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enhanced External conterpulsation

aspirin

Arm Description

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.

The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.

Outcomes

Primary Outcome Measures

visual acuity

Secondary Outcome Measures

Ophthalmic artery blood flow velocity

Full Information

First Posted
January 8, 2013
Last Updated
March 29, 2017
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01768260
Brief Title
Effect of EECP on Anterior Ischemic Optic Neuropathy
Acronym
AION
Official Title
Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Ischemic Optic Neuropathy
Keywords
visual acuity, artery flow velocity, Enhanced External Counterpulsation, Ischemic, Optic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced External conterpulsation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
aspirin
Arm Type
Active Comparator
Arm Description
The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.
Intervention Type
Device
Intervention Name(s)
Enhanced external counterpulsation
Other Intervention Name(s)
EECP
Intervention Description
EECP is performed for 1 hours every day, for a total of 36 hours.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Standard drug therapy
Primary Outcome Measure Information:
Title
visual acuity
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Ophthalmic artery blood flow velocity
Time Frame
7 weeks
Other Pre-specified Outcome Measures:
Title
Central retinal artery flow velocity
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ischemic optic neuropathy within 1 month Exclusion Criteria: Hemorrhagic disease thrombophlebitis or infection lesions severe hypertensive patients Atrial fibrillation Aortic regurgitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, MD
Phone
862087755766
Ext
8141
Email
Zhyan3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Professor
Organizational Affiliation
First Affiliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat- sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Zhang, MA
Phone
862087755766
Ext
8035
Email
Zhanglingaben@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15300074
Citation
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. doi: 10.1097/00006982-200408000-00006.
Results Reference
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Effect of EECP on Anterior Ischemic Optic Neuropathy

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