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Completed

NCT Number: NCT02617368

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

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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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Institute Of Thrace

Alexandroupoli, Evros, 68100, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Spherical Component (SphRmin)

    Time frame: One Day

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

  2. Spherical Eccentricity (SphEcc)

    Time frame: One Day

    Spherical Eccentricity is the asphericity that is calculated

  3. Maximum Decentration (MaxDec)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: One Day

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

  7. Irregularitiy (Irr)

    Time frame: one Day

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

    Time frame: 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.

    Time frame: One Day

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

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Acronym: FFTKC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Dec 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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