Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy
Pilot-SINN
Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)
1 other identifier
observational
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedMay 28, 2014
May 1, 2014
1.8 years
June 4, 2012
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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)
Interventions
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 EDTRS chart
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
Eligibility Criteria
Patients with acute N-AION (less then 7 days); male and female \> 18 years
You may qualify if:
- willingness to comply with the protocol (4 visits)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- University Hospital Freiburgcollaborator
Study Sites (1)
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
Related Publications (1)
Kernstock C, Beisse F, Wiethoff S, Mast A, Krapp E, Grund R, Dietzsch J, Lagreze 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 Ophthalmol. 2014 Mar;252(3):515-21. doi: 10.1007/s00417-014-2572-z. Epub 2014 Jan 31.
PMID: 24477537RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Schiefer, Prof.
Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dr. med. Ulrich Schiefer
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 7, 2012
Study Start
April 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
May 28, 2014
Record last verified: 2014-05