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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension, Normal Tension Glaucoma

Status

Terminated

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

7-Tesla MRI

Optical Coherence Tomography

Heidelberg Retina Tomography

Scanning Laser Polarimetry

Humphrey Perimetry

Applanation Tonometry

About this trial

This is an interventional basic science trial for Primary Open Angle Glaucoma focused on measuring 7-Tesla Magnetic Resonance Imaging, Intraocular Pressure, Retinal Nerve Fiber Thickness, Visual Field Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Arm Label

Primary Open Angle Glaucoma

Normal Tension Glaucoma

Ocular Hypertension

Healthy subjects

Arm Description

30 patients with primary open angle glaucoma

30 patients with normal tension glaucoma

30 patients with ocular hypertension

30 healthy control subjects

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Retinal nerve fiber thickness

Parameters obtained from GDX and OCT measurements will be compared between groups.

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.

Intraocular Pressure

Goldmann applanation tonometry will be used for measurement of intraocular pressure.

Full Information

NCT ID

NCT01864317

First Posted

May 3, 2013

Last Updated

August 21, 2019

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01864317

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma, Ocular Hypertension, Normal Tension Glaucoma

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Primary Open Angle Glaucoma

Arm Type

Experimental

Arm Description

30 patients with primary open angle glaucoma

Arm Title

Normal Tension Glaucoma

Arm Type

Experimental

Arm Description

30 patients with normal tension glaucoma

Arm Title

Ocular Hypertension

Arm Type

Experimental

Arm Description

30 patients with ocular hypertension

Arm Title

Healthy subjects

Arm Type

Other

Arm Description

30 healthy control subjects

Intervention Type

Device

Intervention Name(s)

7-Tesla MRI

Intervention Description

High resolution functional and structural imaging of the visual pathway

Intervention Type

Other

Intervention Name(s)

Optical Coherence Tomography

Intervention Description

Measurement of retinal nerve fiber thickness

Intervention Type

Other

Intervention Name(s)

Heidelberg Retina Tomography

Intervention Description

Measurement of retinal nerve fiber thickness

Intervention Type

Other

Intervention Name(s)

Scanning Laser Polarimetry

Intervention Description

Measurement of retinal nerve fiber thickness

Intervention Type

Other

Intervention Name(s)

Humphrey Perimetry

Intervention Description

Visual Field Testing

Intervention Type

Other

Intervention Name(s)

Applanation Tonometry

Intervention Description

Measurement of Intraocular Pressure

Primary Outcome Measure Information:

Title

High resolution functional and structural imaging of the visual pathway

Description

The visual pathway will be imaged with 7-Tesla MRI. The images will be compared between the study groups.

Time Frame

once on the study day (approximately 1 hour)

Secondary Outcome Measure Information:

Title

Retinal nerve fiber thickness

Description

Parameters obtained from GDX and OCT measurements will be compared between groups.

Time Frame

once on the study day (approximately 10 minutes)

Title

Visual field test

Description

Parameters from the Humphrey visual field test will be used for classification of severity of glaucoma or to prove that subjects are healthy.

Time Frame

once on the study day (approximately 20 minutes)

Title

Intraocular Pressure

Description

Goldmann applanation tonometry will be used for measurement of intraocular pressure.

Time Frame

once on the study day (1 minute)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhoefer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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

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