Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (Pilot-SINN)

This study has been completed.
Sponsor:
Collaborator:
University Hospital Freiburg
Information provided by (Responsible Party):
Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01614158
First received: June 4, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.

Condition Intervention
Non-arteritic Ischemic Optic Neuropathy
Other: perimetry
Other: D-BCVA
Other: RAPD
Other: IOP
Other: Spectralis OCT
Other: Fundus photography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 16
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Other: 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 Name: Static Perimetry, Octopus 101, thresholding algorithm
Other: D-BCVA
D-BCVA using EDTRS chart
Other Name: Best Corrected Visual Acuity, EDTRS Chart
Other: RAPD
RAPD using swinging flashlight test
Other Name: SWIFT-Test
Other: IOP
IOP using applanation tonometer
Other Name: intraocular pressure
Other: Spectralis OCT
RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)
Other Name: RNFT, RNFV, volume scan, star scan, Spectralis OCT
Other: Fundus photography
Optic disk morphology will be documented by fundus photography
Other Name: Fundus photography

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute N-AION (less then 7 days); male and female > 18 years

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614158

Locations
Germany
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Württemberg, Germany
Sponsors and Collaborators
University Hospital Tuebingen
University Hospital Freiburg
Investigators
Principal Investigator: Ulrich Schiefer, Prof. Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
  More Information

No publications provided

Responsible Party: Ulrich Schiefer, Professor Dr. med. Ulrich Schiefer, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01614158     History of Changes
Other Study ID Numbers: 73/2009B02
Study First Received: June 4, 2012
Last Updated: June 14, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
N-AION
perimetry
visual field loss
Mean Defect
Total Loss Volume
D-BCVA
RAPD
retinal nerve fibre thickness/volume
optic nerve head

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 23, 2014