NCT01068938Unknown不适用
Detection of Visual Field Defects and Scotoma Progression in Glaucomatous Optic Neuropathy, Using Short-term Intervals With Automated Scotoma-oriented Perimetry (SCOPE) and the Fast Thresholding Strategy GATE (German Adaptive Threshold Estimation)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- glaucoma progression
研究概览
简要总结
The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •max. ± 8 dpt sph, max. ± 3 dpt cyl
- •distant visual acuity > 10/20
- •isocoria, pupil diameter > 3 mm
- •at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (CDR) > 0.7 / inter-eye asymmetry of CDR >0.2 / notching of the optic disc /retinal nerve fibre layer (RNFL) defects / intraocular pressure( IOP) >22 mmHg / central corneal thickness < 520 µm / advanced visual field defect stage Aulhorn III / elder than 70 years
排除标准
- •pregnancy, nursing
- •diabetic retinopathy
- •HIV+ or AIDS
- •history of epilepsy or significant psychiatric disease
- •medications known to effect visual field sensitivity
- •infections (e.g. keratitis, conjunctivitis, uveitis)
- •severe dry eyes
- •miotic drug
- •amblyopia
- •nystagmus
- •any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate IOP readings
- •keratoconus
- •intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening
- •history or signs of any visual pathway affection other than glaucoma
- •allergies with regard to topic glaucoma medication
- •history or presence of macular disease and / or macular edema
- •ocular trauma
- •medications known to affect visual field sensitivity
结局指标
主要结局
glaucoma progression
时间窗: 6 month
次要结局
未报告次要终点
研究者
Ulrich Schiefer
Prof. Dr. med.
University Hospital Tuebingen
研究点 (1)
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