NCT02617368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

December 1, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 23, 2015

Last Update Submit

November 25, 2015

Conditions

Keratoconus

Keywords

Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data

Outcome Measures

Primary Outcomes (9)

  • Spherical Component (SphRmin)

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

    One Day

  • Spherical Eccentricity (SphEcc)

    Spherical Eccentricity is the asphericity that is calculated

    One Day

  • Maximum Decentration (MaxDec)

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

    One Day

  • 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

  • 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

  • Mean Astigmatism (MAst)

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

    One Day

  • Irregularitiy (Irr)

    one Day

  • 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

  • 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

Study Arms (3)

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.

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Institute Of Thrace

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor in Ophthalmology

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 1, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 1, 2015

Record last verified: 2015-11

Locations

GR(1)