Primary Open Angle GlaucomaPhase 2NCT01864317
Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging
A Phase 2 study testing 7-Tesla MRI, Optical Coherence Tomography and Heidelberg Retina Tomography in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension, Normal Tension Glaucoma
- What is being tested?
- 7-Tesla MRI, Optical Coherence Tomography and Heidelberg Retina Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2015to Dec 2015
- Phase
- Phase 2
- 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
- Healthy controls
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings
- Patients with ocular hypertension
- Men and women aged over 18 years
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- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings except presence of ocular hypertension (defined as untreated IOP ≥ 21 mmHg on at least three measurements in the medical history, no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test)
- Patients with primary open angle glaucoma
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Diagnosis of manifest primary open angle glaucoma (defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and untreated IOP > 20 mmHg on at least three measurements in the medical history)
- Mean Deviation in the visual field test ≥ 10dB
- Patients with normal-tension glaucoma
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Diagnosis of normal-tension glaucoma (defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and untreated IOP ≤ 20 mmHg on at least three measurements in the medical history)
- Mean Deviation in the visual field test ≥ 10dB
Who cannot join
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
- Intraocular surgery within the last 6 months
- Ocular inflammation or infection within the last 3 months
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- Pregnancy, planned pregnancy or lactating
- Any metallic, electric, electronic or magnetic device or object not removable except dental fillings
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal range. Therefore, other factors must be involved. In the last years, studies using MRI have been performed and evidence has accumulated that also changes in retrobulbar structures are present, in particular in the lateral geniculate nucleus and the visual cortex. However, these studies were limited by the low spatial resolution of the MRI instruments used.
The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and the SC72 high-performance gradient system and is thus perfectly suited for structural and functional imaging. The aim of the present study is to investigate whether structural and functional parameters are altered in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control subjects. The exact topographical survey of intracranial structures such as the LGN and the assessment of neuronal structures by DTI may allow for the better assessment of therapeutic responses to new neuroprotective agents.
- Being tested
- 7-Tesla MRI, Optical Coherence Tomography, Heidelberg Retina Tomography, Scanning Laser Polarimetry, Humphrey Perimetry
- Keywords
- 7-Tesla Magnetic Resonance Imaging, Intraocular Pressure, Retinal Nerve Fiber Thickness, Visual Field Test
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Tesla MRIDevice
High resolution functional and structural imaging of the visual pathway
Optical Coherence TomographyOther
Measurement of retinal nerve fiber thickness
Heidelberg Retina TomographyOther
Measurement of retinal nerve fiber thickness
Scanning Laser PolarimetryOther
Measurement of retinal nerve fiber thickness
Humphrey PerimetryOther
Visual Field Testing
Applanation TonometryOther
Measurement of Intraocular Pressure
| Study group | Role | What they receive |
|---|---|---|
| Primary Open Angle Glaucoma | Experimental | 30 patients with primary open angle glaucoma Receives: Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry |
| Normal Tension Glaucoma | Experimental | 30 patients with normal tension glaucoma Receives: Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry |
| Ocular Hypertension | Experimental | 30 patients with ocular hypertension Receives: Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry |
| Healthy subjects | Other | 30 healthy control subjects Receives: Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
High resolution functional and structural imaging of the visual pathway
The visual pathway will be imaged with 7-Tesla MRI. The images will be compared between the study groups.
Measured: once on the study day (approximately 1 hour)
Secondary outcomes (3)
Retinal nerve fiber thickness
Parameters obtained from GDX and OCT measurements will be compared between groups.
Measured: once on the study day (approximately 10 minutes)
Visual field test
Parameters from the Humphrey visual field test will be used for classification of severity of glaucoma or to prove that subjects are healthy.
Measured: once on the study day (approximately 20 minutes)
Intraocular Pressure
Goldmann applanation tonometry will be used for measurement of intraocular pressure.
Measured: once on the study day (1 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
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 Garhoefer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864317
- Sponsor's protocol ID
- OPHT-220213
- Status last verified
- Aug 2019
- First submitted
- 3 May 2013
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT01864317
- Acronym / sponsor ID
- OPHT-220213
- Keywords
- 7-Tesla Magnetic Resonance Imaging, Intraocular Pressure, Retinal Nerve Fiber Thickness, Visual Field Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 May 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.
Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal range. Therefore, other factors must be involved. In the last years, studies using MRI have been performed and evidence has accumulated that also changes in retrobulbar structures are present, in particular in the lateral geniculate nucleus and the visual cortex. However, these studies were limited by the low spatial resolution of the MRI instruments used.
The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and the SC72 high-performance gradient system and is thus perfectly suited for structural and functional imaging. The aim of the present study is to investigate whether structural and functional parameters are altered in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control subjects. The exact topographical survey of intracranial structures such as the LGN and the assessment of neuronal structures by DTI may allow for the better assessment of therapeutic responses to new neuroprotective agents.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Open Angle Glaucoma | Experimental | Device: 7-Tesla MRI, Other: Optical Coherence Tomography, Other: Heidelberg Retina Tomography, Other: Scanning Laser Polarimetry, Other: Humphrey Perimetry, Other: Applanation Tonometry30 patients with primary open angle glaucoma |
| Normal Tension Glaucoma | Experimental | Device: 7-Tesla MRI, Other: Optical Coherence Tomography, Other: Heidelberg Retina Tomography, Other: Scanning Laser Polarimetry, Other: Humphrey Perimetry, Other: Applanation Tonometry30 patients with normal tension glaucoma |
| Ocular Hypertension | Experimental | Device: 7-Tesla MRI, Other: Optical Coherence Tomography, Other: Heidelberg Retina Tomography, Other: Scanning Laser Polarimetry, Other: Humphrey Perimetry, Other: Applanation Tonometry30 patients with ocular hypertension |
| Healthy subjects | Other | Device: 7-Tesla MRI, Other: Optical Coherence Tomography, Other: Heidelberg Retina Tomography, Other: Scanning Laser Polarimetry, Other: Humphrey Perimetry, Other: Applanation Tonometry30 healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy controls
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings
- Patients with ocular hypertension
Key exclusion criteria (9 listed)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
- Intraocular surgery within the last 6 months
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 |
|---|---|---|
| 7-Tesla MRIHigh resolution functional and structural imaging of the visual pathway | Device | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
| Optical Coherence TomographyMeasurement of retinal nerve fiber thickness | Other | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
| Heidelberg Retina TomographyMeasurement of retinal nerve fiber thickness | Other | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
| Scanning Laser PolarimetryMeasurement of retinal nerve fiber thickness | Other | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
| Humphrey PerimetryVisual Field Testing | Other | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
| Applanation TonometryMeasurement of Intraocular Pressure | Other | Healthy subjects, Normal Tension Glaucoma, Ocular Hypertension, Primary Open Angle Glaucoma |
Primary outcome
High resolution functional and structural imaging of the visual pathway
Time frame: once on the study day (approximately 1 hour)
The visual pathway will be imaged with 7-Tesla MRI. The images will be compared between the study groups.
3 secondary outcomes
Retinal nerve fiber thickness
Time frame: once on the study day (approximately 10 minutes)
Visual field test
Time frame: once on the study day (approximately 20 minutes)
Intraocular Pressure
Time frame: once on the study day (1 minute)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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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 Garhoefer, 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 Phase 2 study testing 7-Tesla MRI, Optical Coherence Tomography and Heidelberg Retina Tomography in people with Primary Open Angle Glaucoma and Ocular Hypertension, 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 18 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Aug 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
High resolution functional and structural imaging of the visual pathway (time frame: once on the study day (approximately 1 hour)). 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 22 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.