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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01614158
Acronym
Pilot-SINN
Enrollment
16
Registered
2012-06-07
Start date
2009-04-30
Completion date
2011-02-28
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-arteritic Ischemic Optic Neuropathy

Keywords

N-AION, perimetry, visual field loss, Mean Defect, Total Loss Volume, D-BCVA, RAPD, retinal nerve fibre thickness/volume, optic nerve head

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.

Interventions

DEVICEperimetry

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

OTHERD-BCVA

D-BCVA using EDTRS chart

OTHERRAPD

RAPD using swinging flashlight test

DEVICEIOP

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

Sponsors

University Hospital Freiburg
CollaboratorOTHER
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)2 yearsThis 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026