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Completed

NCT Number: NCT01614158

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

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.

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Key information

Conditions

Non-arteritic Ischemic Optic Neuropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perimetry

Device

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 names: Static Perimetry, Octopus 101, thresholding algorithm

D-BCVA

Other

D-BCVA using EDTRS chart

Other names: Best Corrected Visual Acuity, EDTRS Chart

RAPD

Other

RAPD using swinging flashlight test

Other names: SWIFT-Test

IOP

Device

IOP using applanation tonometer

Other names: intraocular pressure

Spectralis OCT

Device

RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)

Other names: RNFT, RNFV, volume scan, star scan, Spectralis OCT

Fundus photography

Other

Optic disk morphology will be documented by fundus photography

Primary outcomes

  1. Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • University Hospital Freiburg

Registry information

Official study title

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

Acronym: Pilot-SINN

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2012
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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