Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- reliability of diagnosing OCT biomarkers
研究概览
简要总结
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
详细描述
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. A recent multifactorial analysis outlined macular thickness and DRIL to be significant predictors for postsurgical visual acuity (Karasavviodou et al.). Nevertheless, reliability of diagnosing OCT biomarkes among patients with iERM was not yet assessed, to our knowledge. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •a) presence of an iERM,
- •b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the ERM,
- •c) pseudophakia at the final visit at 3 months after surgery, and
- •d) written informed consent for study participation.
排除标准
- •macular edema caused by conditions other than ERM were excluded from the study.
结局指标
主要结局
reliability of diagnosing OCT biomarkers
时间窗: 1 week
The presence (yes/no) of following OCT biomarkers are diagnosed from preoperative OCTs: EIFL, DRIL, intraretinal cystoid changes, alterations of the ellipsoid zone, cotton ball sign, HR-foci, EMM-rips, and retinal contraction. Intra- and interobserver reliability is assessed from 2 different readers, and reliability of OCT biomarkers will be calculated with the Kuder Richardson 20 test, due to the dichtomic nature of outcomes.
次要结局
- postsurgical best corrected visual acuity(3 months)
- central macular thickness(5 minutes)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Prof., MD, MBA
Vienna Institute for Research in Ocular Surgery