Fourier Transformed Infrared Spectroscopy in Macular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- collagen
研究概览
简要总结
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).
The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.
详细描述
Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.
In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.
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
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms)
- •Age 21 and older
- •written informed consent for surgery and participation in the study prior to surgery
排除标准
- •Macular edema due to other reasons than ERM
- •Hereditary macular disorders
- •In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
结局指标
主要结局
collagen
时间窗: 3 months
occurrence of different types of collagen fibres in the excised membranes
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of the department of Ophthalmology, principal investigator
Vienna Institute for Research in Ocular Surgery