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Recruiting NCT03923101

The Homburg Keratoconus Center (HKC)

— Observational Keratoconus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topographic, tomographic and biomechanical analysis..
Who it may be relevant to
Registry conditions: Keratoconus. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test Topographic, tomographic and biomechanical analysis.
    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).

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Ophthalmology — Homburg

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT03923101 · HKC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗