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FFTKC: Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus

Sponsor
Democritus University of Thrace (Other)
Overall Status
Completed
CT.gov ID
NCT02617368
Collaborator
(none)
185
Enrollment
1
Location
12
Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    185 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    KC group

    KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system
    Forme Fruste Keratoconus Group (FFKG)

    Forme Fruste Keratoconus Group (FFKG) included patients diagnosed with FFK.
    Control Group (CG)

    Control group(CG) was formed by refractive surgery candidates.

    Outcome Measures

    Primary Outcome Measures

    1. Spherical Component (SphRmin) [One Day]

      Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring

    2. Spherical Eccentricity (SphEcc) [One Day]

      Spherical Eccentricity is the asphericity that is calculated

    3. Maximum Decentration (MaxDec) [One Day]

      decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis

    4. Regular Astigmatism at the Center(AstC) [One Day]

      the regular astigmatic component is calculated in the center and it is derived from the second order component of Fourier Analysis

    5. Regular Astigmatism at the Periphery (AstP) [One day]

      the regular astigmatic component is calculated in the periphery and it is derived from the second order component of Fourier Analysis

    6. Mean Astigmatism (MAst) [One Day]

      Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)

    7. Irregularitiy (Irr) [one Day]

    8. Astigmatism at the Center plus the Irregularities (AstCir) [One day]

      the irregularities of the cornea which can not be corrected by sphere, cylinder or prism and it is derived from higher order components of Fourier Analysis of Keratometric Data

    9. Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities. [One Day]

      Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)

    • KISA index between 60 and 100% in the FFK eye (FFKG)

    • lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)

    • uneventful ophthalmologic history (CG)

    • no indications of corneal pathology in slit-lamp biomicroscopy and Placido *disk-based videokeratography (CG)

    • KISA index value less than 60% (CG)

    • diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system (KCG)

    Exclusion Criteria:

    • for all study groups:

    • previous incisional eye surgery

    • corneal scars and opacities

    • history of herpetic keratitis, severe eye dryness

    • pregnancy or nursing

    • current corneal infection

    • glaucoma

    • suspicion for glaucoma

    • IOP lowering treatment

    • underlying autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Institute Of Thrace Alexandroupolis Evros Greece 68100

    Sponsors and Collaborators

    • Democritus University of Thrace

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Georgios Labiris, Ass. Professor in Ophthalmology, Democritus University of Thrace
    ClinicalTrials.gov Identifier:
    NCT02617368
    Other Study ID Numbers:
    • 304/23/11/2015
    First Posted:
    Dec 1, 2015
    Last Update Posted:
    Dec 1, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Georgios Labiris, Ass. Professor in Ophthalmology, Democritus University of Thrace
    Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data
    Additional relevant MeSH terms:
    Keratoconus

    Study Results

    No Results Posted as of Dec 1, 2015