- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774188
the Impact of EECP on Intraocular Pressure
January 19, 2013 updated by: WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University
Study of the Impact of Enhanced Extracorporeal Counterpulsation Treatment on Intraocular Pressure
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wen-hui zhu, MD
- Phone Number: 8400 862087755766
- Email: dctzwh@139.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital of Sun Yat- sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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 .
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intraocular pressure
Time Frame: 7 weeks
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ophthalmic and retina artery blood flow rate
Time Frame: 7 weeks
|
7 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1136/bjo.2004.048710.
- 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. doi: 10.1097/00006982-200408000-00006.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
February 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
January 11, 2013
First Submitted That Met QC Criteria
January 19, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
January 23, 2013
Last Update Submitted That Met QC Criteria
January 19, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- EECP-IOP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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