the Impact of EECP on Intraocular Pressure

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:

NCT01774188

First received: January 11, 2013

Last updated: January 19, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition
Intraocular Pressure

Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration:	7 Weeks
Official Title:	Study of the Impact of Enhanced Extracorporeal Counterpulsation Treatment on Intraocular Pressure

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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

Primary Outcome Measures:

intraocular pressure [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ophthalmic and retina artery blood flow rate [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Blood Pressure [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Detailed Description:

Select 40 cases of patients (80eyes) who had counter pulsation treatment at Enhanced External Counter Pulsation (EECP) Specialist in First Affiliated Hospital of Sun Yat-sen University during Apr 2012 - Mar 2013. Separated the patients into 2 groups according to having glaucoma history or not.The cases whose eyes have erythralgia and who have received corneal surgery or intraocular surgery in recent one month are excluded.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-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 .

Criteria

Inclusion Criteria:

counter Enhanced External Counter Pulsation treatment

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774188

Contacts

Contact: Wen-hui zhu, MD

862087755766 ext 8400

dctzwh@139.com

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

More Information

Publications:

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.

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.

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.

Responsible Party:	WenHui Zhu, Oculist-in-charge, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:	NCT01774188 History of Changes
Other Study ID Numbers:	EECP-IOP
Study First Received:	January 11, 2013
Last Updated:	January 19, 2013
Health Authority:	China: National Natural Science Foundation

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:

Enhanced Extracorporeal Counterpulsation
intraocular pressure
Pen type tonometer

ClinicalTrials.gov processed this record on May 23, 2013

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