The Homburg Keratoconus Center (HKC)

Recruiting

• Conditions: Keratoconus
• Interventions: Diagnostic Test: Topographic, tomographic and biomechanical analysis.

• Registration Number: NCT03923101
• Lead Sponsor: Universität des Saarlandes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2032-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Patients without Keratoconus.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Keratoconus	Topographic, tomographic and biomechanical analysis.	Aim is to include as many Keratoconus patients as possible with the intention to elucidate how the disease begins and develops during lifetime.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology; 🇩🇪 Homburg, Saarland, Germany