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

Keratoconus Clinical Trial

— FFTKC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617368
• Other study ID #: 304/23/11/2015
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 25, 2015
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Keratoconus

Locations

Country	Name	City	State
Greece	Eye Institute Of Thrace	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Component (SphRmin)	Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring	One Day	No
Primary	Spherical Eccentricity (SphEcc)	Spherical Eccentricity is the asphericity that is calculated	One Day	No
Primary	Maximum Decentration (MaxDec)	decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis	One Day	No
Primary	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	One Day	No
Primary	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	One day	No
Primary	Mean Astigmatism (MAst)	Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)	One Day	No
Primary	Irregularitiy (Irr)		one Day	No
Primary	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	One day	No
Primary	Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.	Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.	One Day	No