The Homburg Keratoconus Center (HKC)

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03923101
• Other study ID #: HKC
• Status: Recruiting
• Start date: January 1, 2011
• Est. completion date: January 1, 2032

Study information

• Verified date: November 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 2.000 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without Keratoconus.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Diagnostic Test:
• Topographic, tomographic and biomechanical analysis.
The study is based upon data obtained during routine medical follow-ups using the Pentacam high resolution (Oculus, Wetzlar, Germany) the Corvis ST (Oculus, Wetzlar, Germany) the Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2 (Tomey, Nagoya, Japan) the Ocular Response Analyzer (Reichert Technologies, New York, USA).

Locations

Country	Name	City	State
Germany	Department of Ophthalmology	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An overview about development of anterior corneal curvature in Keratoconus disease during lifetime.	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.	01/01/2011-01/01/2019
Primary	An overview about development of posterior corneal curvature in Keratoconus disease during lifetime.	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.	01/01/2011-01/01/2019
Primary	An overview about development of the thinnest corneal pachymetry in Keratoconus disease during lifetime.	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.	01/01/2011-01/01/2019
Primary	An overview about development of the best corrected distance visual acuity in Keratoconus disease during lifetime.	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.	01/01/2011-01/01/2019
Primary	Reproducibility study: Kmax.	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.	01/01/2011-01/01/2019
Primary	Reproducibility study: Thinnest corneal pachymetry.	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.	01/01/2011-01/01/2019
Primary	Reproducibility study: Thinnest corneal pachymetry at the apex position.	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.	01/01/2011-01/01/2019