Anterior Ischemic Optic NeuropathyAIONNCT01768260
Effect of EECP on Anterior Ischemic Optic Neuropathy
A study testing Enhanced external counterpulsation and Aspirin in people with Anterior Ischemic Optic Neuropathy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Ischemic Optic Neuropathy
- What is being tested?
- Enhanced external counterpulsation and Aspirin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Mar 2018
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ischemic optic neuropathy
- within 1 month
Who cannot join
- Hemorrhagic disease
- thrombophlebitis or infection lesions
- severe hypertensive patients
- Atrial fibrillation
- Aortic regurgitation
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 Effect of EECP on Anterior Ischemic Optic Neuropathy
Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.
Read the detailed description
Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.
- Conditions
- Anterior Ischemic Optic Neuropathy
- Being tested
- Enhanced external counterpulsation, Aspirin
- Keywords
- visual acuity, artery flow velocity, Enhanced External Counterpulsation, Ischemic, Optic Neuropathy
- Medical subject headings
- Optic Neuropathy, Ischemic, Ischemia, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced external counterpulsationDevice
Also called EECP
EECP is performed for 1 hours every day, for a total of 36 hours.
AspirinDrug
Standard drug therapy
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External conterpulsation | Active comparator | Enhanced external counterpulsation (EECP) is a noninvasive modality for the treatment of ischemic cardiovascular disease. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. Receives: Device: Enhanced external counterpulsation; Drug: Aspirin |
| aspirin | Active comparator | The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: 7 weeks
Secondary outcomes (1)
Ophthalmic artery blood flow velocity
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 posted15 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Ischemic Optic NeuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WenHui Zhu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yan Zhang, Professor, Study director, First Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768260
- Sponsor's protocol ID
- Eye EECP-1
- Acronym
- AION
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2013
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15300074
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT01768260
- Acronym / sponsor ID
- AION / Eye EECP-1
- Conditions
- Anterior Ischemic Optic Neuropathy
- Keywords
- visual acuity, artery flow velocity, Enhanced External Counterpulsation, Ischemic, Optic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 15 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.
Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.
Detailed description
Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced External conterpulsation | Active comparator | Device: Enhanced external counterpulsation, Drug: AspirinEnhanced external counterpulsation (EECP) is a noninvasive modality for the treatment of ischemic cardiovascular disease. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. |
| aspirin | Active comparator | Drug: AspirinThe subjects with Anterior ischemic Optic Neuropathy received aspirin therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ischemic optic neuropathy
- within 1 month
Key exclusion criteria (5 listed)
- Hemorrhagic disease
- thrombophlebitis or infection lesions
- severe hypertensive patients
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced external counterpulsationAlso: EECPEECP is performed for 1 hours every day, for a total of 36 hours. | Device | Enhanced External conterpulsation |
| AspirinStandard drug therapy | Drug | Enhanced External conterpulsation, aspirin |
Primary outcome
visual acuity
Time frame: 7 weeks
1 secondary outcome
Ophthalmic artery blood flow velocity
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 31 Mar 2017.
- 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.
- Individual participant dataSharing planned: No
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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.
Yan Zhang, Professor study director
First Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced external counterpulsation and Aspirin in people with Anterior Ischemic Optic Neuropathy, 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 2 inclusion and 5 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 31 Mar 2017. 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 Yan Zhang, MD (862087755766 ext. 8141, Zhyan3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (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 NCT01768260, which also lists 1 linked publication.
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 31 Mar 2017.