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Clinical Trials/NCT03923101
NCT03923101
Recruiting
Not Applicable

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

Universität des Saarlandes2 sites in 1 country5,000 target enrollmentJanuary 1, 2011

Overview

Phase
Not Applicable
Intervention
Topographic, tomographic and biomechanical analysis.
Conditions
Keratoconus
Sponsor
Universität des Saarlandes
Enrollment
5000
Locations
2
Primary Endpoint
An overview about development of anterior corneal curvature in Keratoconus disease during lifetime.
Status
Recruiting
Last Updated
5 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
January 1, 2036
Last Updated
5 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elias Flockerzi

Principal Investigator, Resident of Ophthalmology

University Hospital, Saarland

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patients without Keratoconus.

Arms & Interventions

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.

Intervention: Topographic, tomographic and biomechanical analysis.

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Study Sites (2)

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