跳至主要内容
临床试验/NCT03923101
NCT03923101招募中不适用

The Homburg Keratoconus Center (HKC) - a Keratoconus Observation Study

Universität des Saarlandes2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
2
主要终点
An overview about development of anterior corneal curvature in Keratoconus disease during lifetime.

研究概览

简要总结

Aim of this study is to conduct longitudinal and cross-sectional analyses about the corneal ectatic disease Keratoconus based on data obtained from Keratoconus patients in the Homburg Keratoconus Center (HKC).

The Homburg Keratoconus Center (HKC) was founded in 2010 and, up to now, comprises more than 3,000 Keratoconus patients. Topographic, tomographic and biomechanic characteristics of the disease are being analyzed with the intention to elucidate how the disease begins and develops during lifetime.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • All Keratoconus patients presenting in the department of ophthalmology, Saarland University Medical Center, Homburg, Saarland, Germany.

排除标准

  • Patients without Keratoconus.

研究组 & 干预措施

Patients with Keratoconus

Aim is to include as many Keratoconus patients as possible with the intention to elucidate how the disease begins and develops during lifetime.

干预措施: Topographic, tomographic and biomechanical analysis. (Diagnostic Test)

结局指标

主要结局

An overview about development of anterior corneal curvature in Keratoconus disease during lifetime.

时间窗: 01/01/2011-01/01/2019

The anterior radius of curvature (ARC, 3mm zone) of Keratoconus patients as measured by the Pentacam high resolution (Oculus, Wetzlar, Germany) at different ages (according to: Belin MW and Duncan JK. Keratoconus: The ABCD grading system. Klin Monbl Augenheilkd. 2016; 233(6): 701-707) is put into relation to the age of the Keratoconus patients.

An overview about development of the best corrected distance visual acuity in Keratoconus disease during lifetime.

时间窗: 01/01/2011-01/01/2019

The best corrected distance visual acuity of Keratoconus patients as raised as part of the clinical examination at different ages (according to: Belin MW and Duncan JK. Keratoconus: The ABCD grading system. Klin Monbl Augenheilkd. 2016; 233(6): 701-707) is put into relation to the age of the Keratoconus patients.

Reproducibility study: Kmax.

时间窗: 01/01/2011-01/01/2019

Measurements of Kmax measured by different devices (Pentacam high resolution, Oculus, Wetzlar, Germany; Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2, Tomey, Nagoya, Japan) are being compared and set into relation at different Keratoconus stages with the intention to investigate, whether measurement inaccuracies occur at later Keratoconus stages using different devices.

An overview about development of the thinnest corneal pachymetry in Keratoconus disease during lifetime.

时间窗: 01/01/2011-01/01/2019

The thinnest corneal pachymetry of Keratoconus patients as measured by the Pentacam high resolution (Oculus, Wetzlar, Germany) at different ages (according to: Belin MW and Duncan JK. Keratoconus: The ABCD grading system. Klin Monbl Augenheilkd. 2016; 233(6): 701-707) is put into relation to the age of the Keratoconus patients.

Reproducibility study: Thinnest corneal pachymetry.

时间窗: 01/01/2011-01/01/2019

Measurements of the thinnest corneal pachymetry as measured by different devices (Pentacam high resolution, Oculus, Wetzlar, Germany; Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2, Tomey, Nagoya, Japan) are being compared and set into relation at different Keratoconus stages with the intention to investigate, whether measurement inaccuracies occur at later Keratoconus stages using different devices.

An overview about development of posterior corneal curvature in Keratoconus disease during lifetime.

时间窗: 01/01/2011-01/01/2019

The posterior radius of curvature (PRC, 3mm zone) of Keratoconus patients as measured by the Pentacam high resolution (Oculus, Wetzlar, Germany) at different ages (according to: Belin MW and Duncan JK. Keratoconus: The ABCD grading system. Klin Monbl Augenheilkd. 2016; 233(6): 701-707) is put into relation to the age of the Keratoconus patients.

Reproducibility study: Thinnest corneal pachymetry at the apex position.

时间窗: 01/01/2011-01/01/2019

Measurements of the thinnest corneal pachymetry at the apex position as measured by different devices (Pentacam high resolution, Oculus, Wetzlar, Germany; Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2, Tomey, Nagoya, Japan) are being compared and set into relation at different Keratoconus stages with the intention to investigate, whether measurement inaccuracies occur at later Keratoconus stages using different devices.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elias Flockerzi

Principal Investigator, Resident of Ophthalmology

University Hospital, Saarland

研究点 (2)

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