Status:
TERMINATED
Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging
Lead Sponsor:
Medical University of Vienna
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 desp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01864317
Start Date
November 1 2015
End Date
December 1 2015
Last Update
August 22 2019
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Austria, 1090