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

NCT01654614 | Completed DMC

• 1 other identifier: 62/18.07.2012
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Forme Fruste Keratoconus (FFK)

Keywords

Keratoconus match index; keratoconus probability index; ocular response analyzer; Pentacam; forme fruste keratoconus

Outcome Measures

Primary Outcomes (1)

• Keratoconus Match Index (KMI)

  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

Study Arms (2)

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Eye Institute of Thrace (ΕΙΤ)

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

• Labiris G, Giarmoukakis A, Gatzioufas Z, Sideroudi H, Kozobolis V, Seitz B. Diagnostic capacity of the keratoconus match index and keratoconus match probability in subclinical keratoconus. J Cataract Refract Surg. 2014 Jun;40(6):999-1005. doi: 10.1016/j.jcrs.2013.08.064. Epub 2014 Apr 6.

  PMID: 24713585 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer of Ophthalmology

Study Record Dates

• First Submitted: July 22, 2012
• First Posted: August 1, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

GR (1)