The Homburg Keratoconus Center (HKC)

NCT03923101 | Recruiting

• 1 other identifier: HKC
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Keywords

Keratoconus; Crosslinking; Intracorneal ring segments; Gas-permeable rigid contact-lenses; Penetrating Keratoplasty; Deep anterior lamellar Keratoplasty; ABCD Grading System

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Diagnostic Test: Topographic, tomographic and biomechanical analysis.

Interventions

Topographic, tomographic and biomechanical analysis. DIAGNOSTIC_TEST

The study is based upon data obtained during routine medical follow-ups using 1. the Pentacam high resolution (Oculus, Wetzlar, Germany) 2. the Corvis ST (Oculus, Wetzlar, Germany) 3. the Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2 (Tomey, Nagoya, Japan) 4. the Ocular Response Analyzer (Reichert Technologies, New York, USA).

Patients with Keratoconus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Keratoconus patients of all ages presenting in the department of ophthalmology, Saarland University Medical Center, Homburg, Saarland, Germany, should be included.

You may qualify if:

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

You may not qualify if:

• Patients without Keratoconus.

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Department of Ophthalmology

Homburg, Saarland, 66421, Germany

RECRUITING

Related Publications (9)

• Flockerzi E, Seitz B. Keratectasia severity staging and progression assessment based on the biomechanical E-staging. Eye Vis (Lond). 2024 Jul 1;11(1):24. doi: 10.1186/s40662-024-00392-3.

  PMID: 38946004 RESULT

• Sideroudi H, Flockerzi E, Daas L, Jullien T, Xanthopoulou K, Hamon L, Seitz B. Baseline Characteristics of 1976 Patients With Ectatic Corneal Disorders at a Single Center From 2010 to 2021: A Cross-Sectional Study of the Homburg Keratoconus Center. Eye Contact Lens. 2023 Sep 1;49(9):392-398. doi: 10.1097/ICL.0000000000001014. Epub 2023 Jul 14.

  PMID: 37458424 RESULT

• Flockerzi E, Vinciguerra R, Belin MW, Vinciguerra P, Ambrosio R Jr, Seitz B. Combined biomechanical and tomographic keratoconus staging: Adding a biomechanical parameter to the ABCD keratoconus staging system. Acta Ophthalmol. 2022 Aug;100(5):e1135-e1142. doi: 10.1111/aos.15044. Epub 2021 Oct 16.

  PMID: 34655452 RESULT

• Flockerzi E, Elzer B, Daas L, Xanthopoulou K, Eppig T, Langenbucher A, Seitz B. The Reliability of Successive Scheimpflug Imaging and Anterior Segment Optical Coherence Tomography Measurements Decreases With Increasing Keratoconus Severity. Cornea. 2021 Nov 1;40(11):1433-1439. doi: 10.1097/ICO.0000000000002657.

  PMID: 34633357 RESULT

• Flockerzi E, Vinciguerra R, Belin MW, Vinciguerra P, Ambrosio R Jr, Seitz B. Correlation of the Corvis Biomechanical Factor with tomographic parameters in keratoconus. J Cataract Refract Surg. 2022 Feb 1;48(2):215-221. doi: 10.1097/j.jcrs.0000000000000740.

  PMID: 34321407 RESULT

• Flockerzi E, Hafner L, Xanthopoulou K, Daas L, Munteanu C, Langenbucher A, Seitz B. Reliability analysis of successive Corneal Visualization Scheimpflug Technology measurements in different keratoconus stages. Acta Ophthalmol. 2022 Feb;100(1):e83-e90. doi: 10.1111/aos.14857. Epub 2021 Mar 22.

  PMID: 33750037 RESULT

• Flockerzi E, Xanthopoulou K, Goebels SC, Zemova E, Razafimino S, Hamon L, Jullien T, Kluhspies U, Eppig T, Langenbucher A, Seitz B. Keratoconus staging by decades: a baseline ABCD classification of 1000 patients in the Homburg Keratoconus Center. Br J Ophthalmol. 2021 Aug;105(8):1069-1075. doi: 10.1136/bjophthalmol-2020-316789. Epub 2020 Aug 23.

  PMID: 32830125 RESULT

• Flockerzi E, Berger T, Seitz B, Hamon L, Daas L. Evaluation of dynamic corneal response parameters and the biomechanical E-staging after Intacs(R) SK implantation in keratoconus. Indian J Ophthalmol. 2024 May 1;72(Suppl 3):S495-S500. doi: 10.4103/IJO.IJO_2944_23. Epub 2024 Apr 20.

  PMID: 38648457 DERIVED

• Flockerzi E, Xanthopoulou K, Daas L, Feld S, Langenbucher A, Seitz B. Evaluation of Dynamic Corneal Response Parameters and the Biomechanical E-Staging After Accelerated Corneal Cross-Linking in Keratoconus. Asia Pac J Ophthalmol (Phila). 2022 Nov 1;11(6):514-520. doi: 10.1097/APO.0000000000000580.

  PMID: 36417675 DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Resident of Ophthalmology

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: April 22, 2019
• Study Start: January 1, 2011
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)