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

Completed

• Conditions: Non-arteritic Ischemic Optic Neuropathy
• Interventions: Device: perimetry; Other: D-BCVA; Other: RAPD; Device: IOP; Device: Spectralis OCT; Other: Fundus photography

• Registration Number: NCT01614158
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute N-AION (< 7 d)	perimetry	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)
acute N-AION (< 7 d)	D-BCVA	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)
acute N-AION (< 7 d)	RAPD	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)
acute N-AION (< 7 d)	IOP	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)
acute N-AION (< 7 d)	Spectralis OCT	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)
acute N-AION (< 7 d)	Fundus photography	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany