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Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging

This study is currently recruiting participants.
Verified December 2016 by Gerhard Garhofer, Medical University of Vienna
Sponsor:
ClinicalTrials.gov Identifier:
NCT01864317
First Posted: May 29, 2013
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
  Purpose

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.


Condition Intervention Phase
Primary Open Angle Glaucoma Ocular Hypertension Normal Tension Glaucoma Device: 7-Tesla MRI Other: Optical Coherence Tomography Other: Heidelberg Retina Tomography Other: Scanning Laser Polarimetry Other: Humphrey Perimetry Other: Applanation Tonometry Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging

Resource links provided by NLM:


Further study details as provided by Gerhard Garhofer, Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Retinal nerve fiber thickness [ Time Frame: once on the study day (approximately 10 minutes) ]
    Parameters obtained from GDX and OCT measurements will be compared between groups.

  • Visual field test [ Time Frame: once on the study day (approximately 20 minutes) ]
    Parameters from the Humphrey visual field test will be used for classification of severity of glaucoma or to prove that subjects are healthy.

  • Intraocular Pressure [ Time Frame: once on the study day (1 minute) ]
    Goldmann applanation tonometry will be used for measurement of intraocular pressure.


Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
Device: 7-Tesla MRI
High resolution functional and structural imaging of the visual pathway
Other: Optical Coherence Tomography
Measurement of retinal nerve fiber thickness
Other: Heidelberg Retina Tomography
Measurement of retinal nerve fiber thickness
Other: Scanning Laser Polarimetry
Measurement of retinal nerve fiber thickness
Other: Humphrey Perimetry
Visual Field Testing
Other: Applanation Tonometry
Measurement of Intraocular Pressure
Experimental: Normal Tension Glaucoma
30 patients with normal tension glaucoma
Device: 7-Tesla MRI
High resolution functional and structural imaging of the visual pathway
Other: Optical Coherence Tomography
Measurement of retinal nerve fiber thickness
Other: Heidelberg Retina Tomography
Measurement of retinal nerve fiber thickness
Other: Scanning Laser Polarimetry
Measurement of retinal nerve fiber thickness
Other: Humphrey Perimetry
Visual Field Testing
Other: Applanation Tonometry
Measurement of Intraocular Pressure
Experimental: Ocular Hypertension
30 patients with ocular hypertension
Device: 7-Tesla MRI
High resolution functional and structural imaging of the visual pathway
Other: Optical Coherence Tomography
Measurement of retinal nerve fiber thickness
Other: Heidelberg Retina Tomography
Measurement of retinal nerve fiber thickness
Other: Scanning Laser Polarimetry
Measurement of retinal nerve fiber thickness
Other: Humphrey Perimetry
Visual Field Testing
Other: Applanation Tonometry
Measurement of Intraocular Pressure
Healthy subjects
30 healthy control subjects
Device: 7-Tesla MRI
High resolution functional and structural imaging of the visual pathway
Other: Optical Coherence Tomography
Measurement of retinal nerve fiber thickness
Other: Heidelberg Retina Tomography
Measurement of retinal nerve fiber thickness
Other: Scanning Laser Polarimetry
Measurement of retinal nerve fiber thickness
Other: Humphrey Perimetry
Visual Field Testing
Other: Applanation Tonometry
Measurement of Intraocular Pressure

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

  • 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
  • Pregnancy, planned pregnancy or lactating
  • Any metallic, electric, electronic or magnetic device or object not removable except dental fillings
  • Claustrophobia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864317


Contacts
Contact: Gerhard Garhoefer, MD +43 1 40400 ext 29810 gerhard.garhoefer@meduniwien.ac.at
Contact: Ahmed Bata, MD, MSc +43140400 ext 29880 ahmed.bata@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43 1 40400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Gerhard Garhoefer, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01864317     History of Changes
Other Study ID Numbers: OPHT-220213
First Submitted: May 3, 2013
First Posted: May 29, 2013
Last Update Posted: December 2, 2016
Last Verified: December 2016

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
7-Tesla Magnetic Resonance Imaging
Intraocular Pressure
Retinal Nerve Fiber Thickness
Visual Field Test

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Low Tension Glaucoma
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Optic Nerve Diseases