Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
NCT ID: NCT01614158
Last Updated: 2014-05-28
Study Results
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Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2009-04-30
2011-02-28
Brief Summary
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* perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \[Schiefer 2008\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
* D-BCVA, using FrACT \[Bach 2007\] and EDTRS chart \[Ferris 1982\]
* RAPD (using swinging flashlight test).
* IOP (using applanation tonometer)
* RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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acute N-AION (< 7 d)
physical, intellectual and linguistic abilities, in order to understand the test requirements
* willingness to comply with the protocol (4 visits)
* 45 - 80 years, informed consent
* acute N-AION (\< 7 d)
* D-BCVA \> 0.1 (2/20)
* RAPD ≥ 0.3 logE steps (neutral density filters)
perimetry
perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \[Schiefer 2008\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
D-BCVA
D-BCVA using EDTRS chart
RAPD
RAPD using swinging flashlight test
IOP
IOP using applanation tonometer
Spectralis OCT
RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)
Fundus photography
Optic disk morphology will be documented by fundus photography
Interventions
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perimetry
perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) \[Schiefer 2008\] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
D-BCVA
D-BCVA using EDTRS chart
RAPD
RAPD using swinging flashlight test
IOP
IOP using applanation tonometer
Spectralis OCT
RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)
Fundus photography
Optic disk morphology will be documented by fundus photography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 41 - 80 years, informed consent
* acute N-AION (\< 7 d)
* D-BCVA \> 0.1 (2/20)
* RAPD ≥ 0.3 logE steps (neutral density filters) and:
* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
* isocoria, pupil diameter \> 3 mm
Exclusion Criteria
* history of epilepsy or significant psychiatric disease
* medications known to affect visual field sensitivity
* infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* amblyopia
* strabismus
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings
* cataract with relevant impairment of vision
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than N-AION
* history or presence of macular disease and / or macular edema
* ocular trauma
18 Years
80 Years
ALL
No
Sponsors
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University Hospital Freiburg
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Ulrich Schiefer
Professor Dr. med. Ulrich Schiefer
Principal Investigators
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Ulrich Schiefer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Locations
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Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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References
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Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagreze W, Fischer D, Schiefer U. Assessment of functional and morphometric endpoints in patients with non-arteritic anterior ischemic optic neuropathy (NAION). Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):515-21. doi: 10.1007/s00417-014-2572-z. Epub 2014 Jan 31.
Other Identifiers
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73/2009B02
Identifier Type: -
Identifier Source: org_study_id
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