Assessment of Retinal Photoreceptor Outer Segment Length With Optical Coherence Tomography Before and After Light Stimulation - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Light stimulation
研究概览
简要总结
It has been shown that reactions of human retinal photoreceptors to a light stimulus can be measured with custom-made, research prototype optical coherence tomography (OCT) systems. This can be used as a biomarker for the function of the photoreceptors. Due to the high technical demands on the system, however, the technique is currently not available for clinical purposes. In this pilot study a protocol to measure changes in retinal photoreceptor layer thickness before and after light stimulation shall be developed based on a commercial OCT system and newly developed algorithms. Other variables, such as circadian processes shall be investigated as well. After measurements in healthy volunteers, the protocol is planned to be applied in patients with primary open angle glaucoma (POAG) and age-related macular degeneration (AMD) to test for feasibility of the method in these patient groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women aged over 18 years
- •signed informed consent form
- •ametropia below 3 diopters
- •ability and willingness to follow instructions
- •for healthy volunteers:
- •normal ophthalmologic findings
- •for primary open angle glaucoma patients (POAG):
- •diagnosed POAG
- •MD <= 10 dB
- •for age-related macular degeneration (AMD):
- •diagnosed dry AMD
- •diagnosed stage II or stage III AMD
排除标准
- •Presence of any abnormalities preventing reliable measurements
- •Ocular inflammation and ocular disease interfering with the study aims
- •Use of photosensitizing medication (phototoxic drugs, photoallergic drugs) in the 3 months preceding the study
- •Presence of any condition with the possibility of causing photosensitivity, including systemic lupus erythematosus SLE, Porphyria, Vitiligo, Xeroderma Pigmentosum and Albinism
- •Presence of any form of epilepsy
- •Ocular surgery in the 3 months preceding the study
- •Pregnancy, planned pregnancy or lactating
- •Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
结局指标
主要结局
Light stimulation
时间窗: 1 day
Optical path length changes between inner segment outer segment junction and retinal pigment epithelium (RPE) will be measured with OCT in 15 healthy volunteers, 10 POAG patients and 10 AMD patients before and after light stimulation
次要结局
- Difference in photoreceptor layer thickness over the course of 8 hours(8 hours)
- En face maps(1 day)
- Light stimulation of contralateral eye(1 day)
研究者
Doreen Schmidl
Associate Professor, MD, PhD
Medical University of Vienna