Anterior Ischemic Optic NeuropathyNCT03401892
Retinal Neuro-vascular Coupling in Patients With Non-arteritic Anterior Ischemic Optic Neuropathy
A study testing Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT) in people with Anterior Ischemic Optic Neuropathy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Ischemic optic neuropathy is among the most common causes of serious impaired vision in the middle-aged and elderly population in the western world. The current study focuses on a subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy (NAION). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Ischemic Optic Neuropathy
- What is being tested?
- Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jun 2018to 11 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Men and women aged over 18 years
- History of NAION in one eye
Show all 28Show fewer
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Adequate visual acuity to allow participation in the ocular blood flow measurements
- A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history for at least 30 days prior inclusion, if considered relevant by the investigator.
- Any of the following will exclude a healthy subject from the study:
- Current ocular disease or history of NAION
- Presence or history of a severe medical condition as judged by the clinical investigator
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity < 0.5 Snellen
- Ametropy ≥ 6 Dpt
- Pregnancy or planned pregnancy
- Alcoholism or substance abuse
- Any of the following will exclude a patient from the study:
- Presence or history of a severe medical condition other NAION as judged by the clinical investigator
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity < 0.5 Snellen in the non-affected eye
- Ametropy ≥ 6 Dpt
- Pregnancy, planned pregnancy
- Alcoholism or substance abuse
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Ischemic optic neuropathy is among the most common causes of serious impaired vision in the middle-aged and elderly population in the western world. The current study focuses on a subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy (NAION). Although the exact pathogenesis of NAION has not been fully clarified it is known that patients with cardio-vascular risk factors such as hypertension, diabetes mellitus and dyslipidemia have also an increased risk to develop NAION. Along this line of thought it has been shown that patients with a history of NAION in one eye have an increased risk to develop NAION also on the contralateral eye. However, clinical studies investigating ocular perfusion abnormalities in patients with NAION are sparse and even contradicting. Thus, the current study seeks to measure ocular blood flow parameters in patients with a history of NAION and compare it to healthy age-matched subjects.
- Conditions
- Anterior Ischemic Optic Neuropathy
- Being tested
- Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Optical coherence tomography (OCT)
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vessel Analyzer (DVA)Device
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Device
Retinal blood flow will be assessed using FDOCT.
Optical coherence tomography (OCT)Device
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a history of NAION | Experimental | patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) in one eye Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Optical coherence tomography (OCT) |
| Healthy control subjects | Experimental | healthy age-and sex- matched control subjects Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker light induced hyperemia in retinal vessels
Response of retinal vessels to increased neuronal activity assessed with flicker light
Measured: 1 day
Secondary outcomes (5)
Retinal vessel diameters
Response of retinal vessel diameters to flicker light assessed with DVA
Measured: 1 day
Retinal oxygen saturation
Retinal oxygen saturation measured with DVA
Measured: 1 day
Retinal blood flow
Response of retinal blood flow to flicker light assessed with FDOCT
Measured: 1 day
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness measured using OCT
Measured: 1 day
Central retinal thickness
Central retinal thickness using OCT
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start11 Jun 2018
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401892
- Sponsor's protocol ID
- OPHT-210917
- Status last verified
- Aug 2021
- First submitted
- 10 Jan 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Neuro-vascular Coupling in Patients With Non-arteritic Anterior Ischemic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT03401892
- Acronym / sponsor ID
- OPHT-210917
- Conditions
- Anterior Ischemic Optic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
Ischemic optic neuropathy is among the most common causes of serious impaired vision in the middle-aged and elderly population in the western world. The current study focuses on a subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy (NAION). Although the exact pathogenesis of NAION has not been fully clarified it is known that patients with cardio-vascular risk factors such as hypertension, diabetes mellitus and dyslipidemia have also an increased risk to develop NAION. Along this line of thought it has been shown that patients with a history of NAION in one eye have an increased risk to develop NAION also on the contralateral eye. However, clinical studies investigating ocular perfusion abnormalities in patients with NAION are sparse and even contradicting. Thus, the current study seeks to measure ocular blood flow parameters in patients with a history of NAION and compare it to healthy age-matched subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a history of NAION | Experimental | Device: Dynamic Vessel Analyzer (DVA), Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Optical coherence tomography (OCT)patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) in one eye |
| Healthy control subjects | Experimental | Device: Dynamic Vessel Analyzer (DVA), Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Optical coherence tomography (OCT)healthy age-and sex- matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Men and women aged over 18 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dynamic Vessel Analyzer (DVA)Retinal vessel diameters and oxygen saturation will be measured with the DVA device. | Device | Healthy control subjects, Patients with a history of NAION |
| Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Retinal blood flow will be assessed using FDOCT. | Device | Healthy control subjects, Patients with a history of NAION |
| Optical coherence tomography (OCT)Nerve fiber layer thickness and central retinal thickness will be measured using OCT. | Device | Healthy control subjects, Patients with a history of NAION |
Primary outcome
Flicker light induced hyperemia in retinal vessels
Time frame: 1 day
Response of retinal vessels to increased neuronal activity assessed with flicker light
5 secondary outcomes
Retinal vessel diameters
Time frame: 1 day
Retinal oxygen saturation
Time frame: 1 day
Retinal blood flow
Time frame: 1 day
Retinal nerve fiber layer thickness
Time frame: 1 day
Central retinal thickness
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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.
Gerhard Garhöfer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT) in people with Anterior Ischemic Optic Neuropathy, run by Medical University of Vienna at 1 site in Austria.
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 28 inclusion and 0 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: finished, as of the sponsor's last update on 1 Sep 2021. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker light induced hyperemia in retinal vessels (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2021.