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

May 27, 2014 updated by: Ulrich Schiefer, University Hospital Tuebingen

Pilot SINN; 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:

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany
        • Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 Names:
  • Static Perimetry, Octopus 101, thresholding algorithm
Other: D-BCVA
D-BCVA using EDTRS chart
Other Names:
  • Best Corrected Visual Acuity, EDTRS Chart
Other: RAPD
RAPD using swinging flashlight test
Other Names:
  • SWIFT-Test
Device: IOP
IOP using applanation tonometer
Other Names:
  • intraocular pressure
Device: Spectralis OCT
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
Other: Fundus photography
Optic disk morphology will be documented by fundus photography

What is the study measuring?

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)
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

University Hospital Freiburg

Investigators

  • Principal Investigator: Ulrich Schiefer, Prof., Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73/2009B02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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