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

Non-arteritic Ischemic Optic Neuropathy Clinical Trial

— Pilot-SINN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614158
• Other study ID #: 73/2009B02
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: May 27, 2014
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Non-arteritic Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Device:
• 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

Other:
• D-BCVA
D-BCVA using EDTRS chart
• RAPD
RAPD using swinging flashlight test

Device:
• IOP
IOP using applanation tonometer
• Spectralis OCT
RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)

Other:
• Fundus photography
Optic disk morphology will be documented by fundus photography

Locations

Country	Name	City	State
Germany	Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen	Tübingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagrèze 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No