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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

Tracking Information
First Submitted Date March 22, 2019
First Posted Date April 22, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date January 1, 2011
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Homburg Keratoconus Center (HKC)
Official Title The Homburg Keratoconus Center (HKC) - a Keratoconus Observation Study
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition Keratoconus
Intervention 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).
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Topographic, tomographic and biomechanical analysis.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 19, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2030
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923101
Other Study ID Numbers HKC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elias Flockerzi, Universität des Saarlandes
Study Sponsor Universität des Saarlandes
Collaborators Not Provided
Investigators Not Provided
PRS Account Universität des Saarlandes
Verification Date October 2020