NCT01774188

Brief Summary

EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ blood perfusion the same time. The present study investigated the impact of Enhanced Extracorporeal Counterpulsation treatment on the intraocular pressure.

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 all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

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

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

January 11, 2013

Last Update Submit

January 19, 2013

Conditions

Intraocular Pressure

Keywords

Enhanced Extracorporeal Counterpulsationintraocular pressurePen type tonometer

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    7 weeks

Secondary Outcomes (1)

  • ophthalmic and retina artery blood flow rate

    7 weeks

Other Outcomes (1)

  • Blood Pressure

    7 weeks

Study Arms (2)

Intraocular pressure, EECP, no glaucoma

To examine no glaucoma patients' intraocular pressure before and after the treatment of Enhanced Extracorporeal Counterpulsation. EECP one hour per day, 5 hours a week for a total of 35 hours lasting 7 weeks

intraocular pressure, EECP, glaucoma

To examine glaucoma patients' intraocular pressure before and after the treatment of Enhanced Extracorporeal Counterpulsation. EECP one hour per day, 5 hours a week for a total of 35 hours lasting 7 weeks.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Select 40 cases of patients who had counter pulsation treatment at Enhanced External Counter Pulsation (EECP) Specialist in First Affiliated Hospital of Sun Yat-sen University .

You may qualify if:

  • counter Enhanced External Counter Pulsation treatment

You may not qualify if:

  • whose eyes have erythralgia
  • who have received corneal surgery or intraocular surgery in recent one month
  • Hemorrhagic disease
  • Atrial fibrillation
  • Aortic regurgitation
  • thrombophlebitis or infection lesions
  • severe hypertensive

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 (3)

  • Klein BE, Klein R, Knudtson MD. Intraocular pressure and systemic blood pressure: longitudinal perspective: the Beaver Dam Eye Study. Br J Ophthalmol. 2005 Mar;89(3):284-7. doi: 10.1136/bjo.2004.048710.

    PMID: 15722304BACKGROUND

  • Liu L, Zhou S, Wu G, Zheng Z, Jin Y, Yang S, Zhan C, Fang D, Qian X. [Effects of external counterpulsation on the pulsatility of blood pressure in human subjects]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2002 Sep;19(3):467-70. Chinese.

    PMID: 12557524BACKGROUND

  • 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

Central Study Contacts

Wen-hui zhu, MD

CONTACT

862087755766dctzwh@139.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oculist-in-charge

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 23, 2013

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

CN(1)