Clinical trial NCT03923101: The Homburg Keratoconus Center (HKC)
Official title: The Homburg Keratoconus Center (HKC) - a Keratoconus Observation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keratoconus
Keywords: Keratoconus
Crosslinking
Intracorneal ring segments
Gas-permeable rigid contact-lenses
Penetrating Keratoplasty
Deep anterior lamellar Keratoplasty
ABCD Grading System
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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.

Primary outcomes:
measure: An overview about development of anterior corneal curvature in Keratoconus disease during lifetime.
timeFrame: 01/01/2011-01/01/2019
measure: An overview about development of posterior corneal curvature in Keratoconus disease during lifetime.
timeFrame: 01/01/2011-01/01/2019
measure: An overview about development of the thinnest corneal pachymetry in Keratoconus disease during lifetime.
timeFrame: 01/01/2011-01/01/2019
measure: An overview about development of the best corrected distance visual acuity in Keratoconus disease during lifetime.
timeFrame: 01/01/2011-01/01/2019
measure: Reproducibility study: Kmax.
timeFrame: 01/01/2011-01/01/2019
measure: Reproducibility study: Thinnest corneal pachymetry.
timeFrame: 01/01/2011-01/01/2019
measure: Reproducibility study: Thinnest corneal pachymetry at the apex position.
timeFrame: 01/01/2011-01/01/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Ophthalmology
state: Saarland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.