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

NCT01864317 | Terminated Phase 2 DMC

• 1 other identifier: OPHT-220213
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

Keywords

7-Tesla Magnetic Resonance Imaging; Intraocular Pressure; Retinal Nerve Fiber Thickness; Visual Field Test

Outcome Measures

Primary Outcomes (1)

• 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.

  once on the study day (approximately 1 hour)

Secondary Outcomes (3)

• Retinal nerve fiber thickness

  once on the study day (approximately 10 minutes)

• Visual field test

  once on the study day (approximately 20 minutes)

• Intraocular Pressure

  once on the study day (1 minute)

Study Arms (4)

Primary Open Angle Glaucoma

EXPERIMENTAL

30 patients with primary open angle glaucoma

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

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

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

Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry

Interventions

7-Tesla MRI DEVICE

High resolution functional and structural imaging of the visual pathway

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Optical Coherence Tomography OTHER

Measurement of retinal nerve fiber thickness

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Heidelberg Retina Tomography OTHER

Measurement of retinal nerve fiber thickness

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Scanning Laser Polarimetry OTHER

Measurement of retinal nerve fiber thickness

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Humphrey Perimetry OTHER

Visual Field Testing

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Applanation Tonometry OTHER

Measurement of Intraocular Pressure

Healthy subjects; Normal Tension Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Low Tension Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 29, 2013
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

AU (1)