NCT01614158已完成不适用
Pilot SINN; Assessment of Visual Field (vf)-Related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy (N-AION)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assessment of visual field (VF)-related endpoints in patients with non-arteritic ischemic optic neuropathy (N-AION)
时间窗: 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
次要结局
未报告次要终点
研究者
Ulrich Schiefer
Professor Dr. med. Ulrich Schiefer
University Hospital Tuebingen
研究点 (1)
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