Intraocular PressureNCT01774188
the Impact of EECP on Intraocular Pressure
An observational study of Intraocular Pressure, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Mar 2013
- How long will I take part?
- 7 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- counter Enhanced External Counter Pulsation treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat- sen University
Guangzhou, Guangdong, 510080
Ling Zhang, MA, 862087755766 ext. 8035, Zhanglingaben@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Pressure
- Keywords
- Enhanced Extracorporeal Counterpulsation, intraocular pressure, Pen type tonometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Measured: 7 weeks
Secondary outcomes (1)
ophthalmic and retina artery blood flow rate
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionFeb 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 7 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774188
- Sponsor's protocol ID
- EECP-IOP
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15722304Liu 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.
PubMed 12557524Werner 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.
PubMed 15300074
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Enhanced Extracorporeal Counterpulsation Treatment on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01774188
- Acronym / sponsor ID
- EECP-IOP
- Conditions
- Intraocular Pressure
- Keywords
- Enhanced Extracorporeal Counterpulsation, intraocular pressure, Pen type tonometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (1 listed)
- counter Enhanced External Counter Pulsation treatment
Key exclusion criteria (7 listed)
- whose eyes have erythralgia
- who have received corneal surgery or intraocular surgery in recent one month
- Hemorrhagic disease
- Atrial fibrillation
- Aortic regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraocular pressure
Time frame: 7 weeks
1 secondary outcome
ophthalmic and retina artery blood flow rate
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Background: PubMed 15722304Klein 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.
- Background: PubMed 12557524Liu 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.
- Background: PubMed 15300074Werner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-hui zhu, MD (862087755766 ext. 8400, dctzwh@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.