the Impact of EECP on Intraocular Pressure

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014