Diagnostic Capacity of Keratoconus Match Index and Keratoconus Match Probability in Forme Fruste Keratoconus

January 14, 2017 updated by: Georgios Labiris, Democritus University of Thrace

Primary objective of this study was to evaluate the diagnostic capability of keratoconus match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.

All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Eye Institute of Thrace (ΕΙΤ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Exclusion Criteria:

for both 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratoconus Match Index (KMI)
Time Frame: one day

KMI is the outcome of a neural network calculation of seven ORA-derived waveform scores and represents the similarity of the waveform of the examined eye against the same average waveform scores of the keratoconus eyes in the machine's database.

Receiver operating characteristics (ROC) curves were applied to determine the overall predictive accuracy of KMI parameter,as described by the area under the curve (AUC), in differentiating FFK cases from normal ones. The impact of Pentacam-derived KC related indexes on KMI was assessed with stepwise forward multivariate regression analysis.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 22, 2012

First Submitted That Met QC Criteria

July 29, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62/18.07.2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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