NCT00396188已完成不适用
Corneal Analysis - Pathology Detection Aid
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 769
- 试验地点
- 4
- 主要终点
- Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer
研究概览
简要总结
The purpose of this study is to determine the ability of a proprietary software screening tool to discriminate normal corneas (front surface of the eye) from previously diagnosed corneal conditions (diseases/surgeries/pathologies) and to determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas.
详细描述
- To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
- To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
- To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
- To establish reference values for SF, CIM, and TKM in subjects with previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface that are not listed above.
- To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
- To determine the sensitivity, specificity, and accuracy of the Pathfinder II Corneal Analysis software in discriminating normal corneas from previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface (Phase II).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patients seeking initial laser vision correction that were screened to be good candidates for the procedure.
- •No history of refractive or other ocular surgery.
- •No corneal pathologies.
- •Normal corneal topography.
- •Contact lens wearers should discontinue use at least 2 weeks for hard contacts, and 3 days for soft lenses prior to imaging.
- •Keratoconus
- •An irregular cornea determined by distorted keratometry mires, distortion of the retinoscopic, or ophthalmoscopic red reflex (or a combination of these)
- •At least one of the following biomicroscopic signs: Vogt's striae, Fleischer's ring of >2 mm arc, or corneal scarring consistent with keratoconus.
- •Contact lens wearers should discontinue use preferably 1 day or at least half an hour prior to imaging.
- •Myopic Laser Vision Correction
- •Patients who have undergone myopic:
- •Hyperopic Laser Vision Correction
- •Patients who have undergone hyperopic:
- •Orthokeratology
- •Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
- •Subjects must be 18 years of age or older; able and willing to make the required visit; and able and willing to give consent.
排除标准
- •Patients that underwent corneal transplantation or any ocular surgery for the following categories: normal, keratoconus, and orthokeratology)
- •Any active infection or inflammation of the cornea.
- •PI decides that subject is not suitable due to medical risk.
结局指标
主要结局
Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer
时间窗: 1-2 hours
次要结局
- Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas(1-2 hours)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE FittingCorneal TraumaOcular Surface DiseasePellucid Marginal Corneal DegenerationEctasiaCorneal ScarDry Eye SyndromesSjogren's SyndromeKeratoconjunctivitis SiccaKeratoconusNCT04649177Boston Sight11
已完成
不适用
Computer-aided Diagnosis of Ocular Diseases Based on Corneal BiomechanicsCorneal EctasiaCorneal DiseaseCorneal AstigmatismGlaucomaOpen Angle GlaucomaNormal Tension GlaucomaKeratoconusNCT04475900Technische Universität Dresden372
招募中
不适用
Identification and Measurement of Antioxidants and Cytokines in the Anterior Chamber of Various Ocular DisordersEye DiseasesNCT04101591Chang Gung Memorial Hospital200
已完成
不适用
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)HealthyNCT00347594Bausch & Lomb Incorporated76
已完成
不适用
Astigmatic Vector Analysis of Posterior Cornea - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus CorneasKeratoconusNCT02698709University of Sao Paulo698