NCT03318510Unknown不适用
Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma - a Pilot Study
Augenabteilung Allgemeines Krankenhaus Linz2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean blur ratio (LSFG)
研究概览
简要总结
Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian men and women aged over 50 years
- •Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study
- •Normal open angle in a gonioscopic examination
- •Presence of glaucomatous optic disc changes in biomicroscopy and
- •Visual field defects in at least two visual field examinations (Reliability criteria: fixation errors < 20%, false positives < 15%, and false negatives < 33%) Or
- •Abnormal circumpapillary retinal nerve fiber layer thinning (RNFL evaluated by OCT)
排除标准
- •History of ocular or systemic disease causing optic nerve damage
- •History of IOP greater than 21 mm Hg (corrected by CCT)
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- •Ametropia > 6 Dpt
- •pre- or perimenopausal women
- •Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. optic nerve head drusen, tilted disc, etc.)
- •Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
- •Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- •Blood donation in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Ocular infection or clinically significant inflammation
- •Pregnancy, planned pregnancy or lactating
结局指标
主要结局
Mean blur ratio (LSFG)
时间窗: 4 seconds
次要结局
- Pulse-waveform parameters (LSFG)(4 seconds)
研究者
Matthias Bolz
Prof.
Augenabteilung Allgemeines Krankenhaus Linz
研究点 (2)
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