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

Phase 2

Terminated

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Normal Tension Glaucoma
• Interventions: Device: 7-Tesla MRI; Other: Optical Coherence Tomography; Other: Heidelberg Retina Tomography; Other: Scanning Laser Polarimetry; Other: Humphrey Perimetry; Other: Applanation Tonometry

• Registration Number: NCT01864317
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Study Start: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Heidelberg Retina Tomography	30 healthy control subjects
Primary Open Angle Glaucoma	Scanning Laser Polarimetry	30 patients with primary open angle glaucoma
Normal Tension Glaucoma	Optical Coherence Tomography	30 patients with normal tension glaucoma
Primary Open Angle Glaucoma	Optical Coherence Tomography	30 patients with primary open angle glaucoma
Primary Open Angle Glaucoma	Applanation Tonometry	30 patients with primary open angle glaucoma
Primary Open Angle Glaucoma	7-Tesla MRI	30 patients with primary open angle glaucoma
Primary Open Angle Glaucoma	Humphrey Perimetry	30 patients with primary open angle glaucoma
Normal Tension Glaucoma	Heidelberg Retina Tomography	30 patients with normal tension glaucoma
Normal Tension Glaucoma	Applanation Tonometry	30 patients with normal tension glaucoma
Ocular Hypertension	7-Tesla MRI	30 patients with ocular hypertension
Ocular Hypertension	Heidelberg Retina Tomography	30 patients with ocular hypertension
Normal Tension Glaucoma	Humphrey Perimetry	30 patients with normal tension glaucoma
Primary Open Angle Glaucoma	Heidelberg Retina Tomography	30 patients with primary open angle glaucoma
Normal Tension Glaucoma	7-Tesla MRI	30 patients with normal tension glaucoma
Healthy subjects	7-Tesla MRI	30 healthy control subjects
Healthy subjects	Scanning Laser Polarimetry	30 healthy control subjects
Healthy subjects	Humphrey Perimetry	30 healthy control subjects
Normal Tension Glaucoma	Scanning Laser Polarimetry	30 patients with normal tension glaucoma
Ocular Hypertension	Applanation Tonometry	30 patients with ocular hypertension
Ocular Hypertension	Scanning Laser Polarimetry	30 patients with ocular hypertension
Ocular Hypertension	Humphrey Perimetry	30 patients with ocular hypertension
Ocular Hypertension	Optical Coherence Tomography	30 patients with ocular hypertension
Healthy subjects	Optical Coherence Tomography	30 healthy control subjects
Healthy subjects	Applanation Tonometry	30 healthy control subjects

Primary Outcome Measures

Name	Time	Method
High resolution functional and structural imaging of the visual pathway	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

Name	Time	Method
Visual field test	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	once on the study day (1 minute)	Goldmann applanation tonometry will be used for measurement of intraocular pressure.
Retinal nerve fiber thickness	once on the study day (approximately 10 minutes)	Parameters obtained from GDX and OCT measurements will be compared between groups.

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria