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CompletedNCT02617368FFTKCUpdated Dec 1, 2015

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

An observational study in Keratoconus, sponsored by Democritus University of Thrace. Completed at 1 site in Greece. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2015-12-01.

Sponsored by Democritus University of Thrace · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
185
Ages
8 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Keratoconus

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Keywords

  • Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data
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In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 185 is above the median of 130 across 94 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All participants were recruited from the Outpatients Cornea service, in a consecutive if eligible basis

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
185 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Spherical Component (SphRmin)

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

    Time frame: One Day

  2. Spherical Eccentricity (SphEcc)

    Spherical Eccentricity is the asphericity that is calculated

    Time frame: One Day

  3. Maximum Decentration (MaxDec)

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

    Time frame: One Day

  4. Regular Astigmatism at the Center(AstC)

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

    Time frame: One Day

  5. Regular Astigmatism at the Periphery (AstP)

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

    Time frame: One day

  6. Mean Astigmatism (MAst)

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

    Time frame: One Day

  7. Irregularitiy (Irr)

    Time frame: one Day

  8. Astigmatism at the Center plus the Irregularities (AstCir)

    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

    Time frame: One day

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

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

    Time frame: One Day

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Study locations

1 site
  • Eye Institute Of Thrace
    Alexandroupolis, Evros 68100, Greece
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02617368
Lead sponsor
Democritus University of Thrace
Responsible party
Georgios Labiris (Ass. Professor in Ophthalmology, Democritus University of Thrace) — Principal investigator
First posted
Dec 1, 2015
Start date
Nov 2014
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Dec 1, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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