Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)

Conditions
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Non-arteritic Ischemic Optic Neuropathy

Intervention / Treatment
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* Device: perimetry
* Other: D-BCVA
* Other: RAPD
* Device: IOP
* Device: Spectralis OCT
* Other: Fundus photography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute N-AION (< 7 d)<br>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) | Device: perimetry<br>* 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<br>* Other names: Static Perimetry, Octopus 101, thresholding algorithm;Other: D-BCVA<br>* D-BCVA using EDTRS chart<br>* Other names: Best Corrected Visual Acuity, EDTRS Chart;Other: RAPD<br>* RAPD using swinging flashlight test<br>* Other names: SWIFT-Test;Device: IOP<br>* IOP using applanation tonometer<br>* Other names: intraocular pressure;Device: Spectralis OCT<br>* RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)<br>* Other names: RNFT, RNFV, volume scan, star scan, Spectralis OCT;Other: Fundus photography<br>* Optic disk morphology will be documented by fundus photography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION) | This present research project intends to collect five quantitative test series in order to allow the 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-AION, perimetry, visual field loss, Mean Defect, Total Loss Volume, D-BCVA, RAPD, retinal nerve fibre thickness/volume, optic nerve head