Clinical trial NCT01614158: Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Official title: Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-arteritic Ischemic Optic Neuropathy
Keywords: N-AION
perimetry
visual field loss
Mean Defect
Total Loss Volume
D-BCVA
RAPD
retinal nerve fibre thickness/volume
optic nerve head
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
First posted: 2012-06-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute N-AION (less then 7 days); male and female \> 18 years

Brief summary: This present research project intends to collect five quantitative test series:

* 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.


Eligibility criteria: Inclusion Criteria: - physical, intellectual and linguistic abilities, in order to understand the test requirements

* willingness to comply with the protocol (4 visits)
* 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:

* diabetic retinopathy and any other orbital, intracranial or optic nerve disease
* 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

Primary outcomes:
measure: Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
state: Baden-Württemberg
Study officials:
affiliation: Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
name: Ulrich Schiefer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.