Clinical trial NCT02617368: Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus
Official title: Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 185
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants were recruited from the Outpatients Cornea service, in a consecutive if eligible basis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Spherical Component (SphRmin)
timeFrame: One Day
measure: Spherical Eccentricity (SphEcc)
timeFrame: One Day
measure: Maximum Decentration (MaxDec)
timeFrame: One Day
measure: Regular Astigmatism at the Center(AstC)
timeFrame: One Day
measure: Regular Astigmatism at the Periphery (AstP)
timeFrame: One day
measure: Mean Astigmatism (MAst)
timeFrame: One Day
measure: Irregularitiy (Irr)
timeFrame: one Day
measure: Astigmatism at the Center plus the Irregularities (AstCir)
timeFrame: One day
measure: Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Eye Institute Of Thrace
state: Evros
Study officials:
References: