Trial record 13 of 246 for:    Open Studies | "Glaucoma"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01864317
First received: May 3, 2013
Last updated: May 24, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Goldmann applanation tonometry will be used for measurement of intraocular pressure.


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864317

Contacts
Contact: Gerhard Garhoefer, MD +43 1 40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology Not yet 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

No publications provided

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
Study First Received: May 3, 2013
Last Updated: May 24, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on September 14, 2014