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The Homburg Keratoconus Center (HKC)

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ClinicalTrials.gov Identifier: NCT03923101
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Elias Flockerzi, Universität des Saarlandes

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 1.200 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.


Condition or disease Intervention/treatment
Keratoconus Diagnostic Test: Topographic, tomographic and biomechanical analysis.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: The Homburg Keratoconus Center (HKC) - a Keratoconus Observation Study
Actual Study Start Date : January 1, 2011
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without Keratoconus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923101


Locations
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Germany
Department of Ophthalmology Recruiting
Homburg, Saarland, Germany, 66421
Contact: Elias Flockerzi, Dr.med.    0049-6841-16-22302    elias.flockerzi@uks.eu   
Contact: Berthold Seitz, Prof.Dr.med.    0049-6841-16-22387    berthold.seitz@uks.eu   
Sponsors and Collaborators
Universität des Saarlandes
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Responsible Party: Elias Flockerzi, Principal Investigator, Resident of Ophthalmology, Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT03923101    
Other Study ID Numbers: HKC
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elias Flockerzi, Universität des Saarlandes:
Keratoconus
Crosslinking
Intracorneal ring segments
Gas-permeable rigid contact-lenses
Penetrating Keratoplasty
Deep anterior lamellar Keratoplasty
ABCD Grading System
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases