NCT01768260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

January 8, 2013

Last Update Submit

March 29, 2017

Conditions

Anterior Ischemic Optic Neuropathy

Keywords

visual acuityartery flow velocityEnhanced External CounterpulsationIschemicOptic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    7 weeks

Secondary Outcomes (1)

  • Ophthalmic artery blood flow velocity

    7 weeks

Other Outcomes (1)

  • Central retinal artery flow velocity

    7 weeks

Study Arms (2)

Enhanced External conterpulsation

ACTIVE COMPARATOR

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 counterpulsationDrug: Aspirin

aspirin

ACTIVE COMPARATOR

The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.

Drug: Aspirin

Interventions

Enhanced external counterpulsationDEVICE

EECP is performed for 1 hours every day, for a total of 36 hours.

Also known as: EECP
Enhanced External conterpulsation
AspirinDRUG

Standard drug therapy

Enhanced External conterpulsationaspirin

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ischemic optic neuropathy
  • within 1 month

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related 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. doi: 10.1097/00006982-200408000-00006.

    PMID: 15300074BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, IschemicIschemiaOptic Nerve Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yan Zhang, Professor

    First Affiliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Yan Zhang, MD

CONTACT

862087755766Zhyan3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oculist-in-charge

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 15, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)