Identification and Validation of Functional Biomarkers for Keratoconus

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Brief Title

Identification and Validation of Functional Biomarkers for Keratoconus

Official Title

Identification of Disease Progression Specific Biomarkers and Their Pharmacologic Modulation for Keratoconus.

Brief Summary

      There is currently no medication for containing KC, nor any adequate biomarkers to predict
      the disease. Furthermore, there is considerable confusion in the field regarding the
      pathophysiology of the disease and involvement of inflammation. To that end, this study is
      designed to address some of these questions by determining the proteomic profiles of KC
      patients with different clinical grades. This relatively large cohort study is expected to
      yield significant information regarding the molecules that are deregulated during progression
      of KC and may provide a framework to assign diagnostic biomarkers and therapeutic
      intervention points.
    

Detailed Description

      The screening of keratoconus involves keratoconus related clinical signs like retinoscopy
      scissors reflex, Munson sign, stromal thinning, Vogt's striae, and Fleischer's ring, but
      corneal topography is the most useful method in the diagnosis of keratoconus, especially in
      the absence of clinical signs.

      Several devices are currently available for detecting early keratoconus by measuring anterior
      and posterior corneal topography and elevation(Mihaltz et al. 2009; Ishii et al. 2012).
      Corneal topographic and tomographic techniques which generate color-coded maps and
      topographic indices, are the most sensitive devices for confirming the diagnosis of
      keratoconus(Rabinowitz 1998; Rao et al. 2002) were used for diagnosis in this study. In
      addition, videokeratography has been shown to identify Forme fruste keratoconus (FFKC) in the
      absence of clinical signs of keratoconus. Videokeratographic indices such as the Klyce/Maeda
      criteria, the Rabinowitz criteria, and others have been developed to quantitatively analyze
      videokeratography and screen for keratoconus(Rao et al. 2002). These indices have been shown
      to identify keratoconus with a high degree of sensitivity and specificity. The Orbscan II is
      a three-dimensional slit-scan topography system for analysis of the corneal surfaces and
      anterior chamber and has been used on all patients in the study. It uses calibrated video and
      a scanning slit beam to measure x, y, and z locations of several thousand points. These
      points are used to construct topographic maps(Rao et al. 2002). The Pentacam (Oculus Inc) is
      a corneal tomographer technology which generates data on topograophy and elevation of
      anterior and posterior using a rotating Scheimpflug camera which has also been used on all
      subjects enrolled in this study. Various diagnostic parameters are available for keratoconus
      diagnosis depending on what mode of topography is being used. Maeda and Klyce designed a
      system to detect keratoconus. The system, which is based on linear discriminant analysis and
      a binary decision tree, identifies the map as representing keratoconus or nonkeratoconus and,
      based on a value from the discriminant analysis (the KPI), assigns the map an index expressed
      as a percentage that suggests the severity of keratoconus. At this time, however, Keratoconus
      Severity Index (KSI) and the Amsler-Krumeich classification are the most popular methods for
      grading keratoconus severity(Mihaltz et al. 2009; Ishii et al. 2012). KSI is based on indices
      estimated by a curvature map using Placido disk-based corneal topography, and Amsler-Krumeich
      classification defines the stage of keratoconus using biomicroscopy, mean central keratometry
      reading, spherical and cylindrical refraction change, and corneal thickness(Mihaltz et al.
      2009; Ishii et al. 2012). This is the index that has been used for the final gradation of
      keratoconus stages of all subjects in this study.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Keratoconus grade specific biomarker identification

Secondary Outcome

 Onlabel use of anti-allergic topical treatment for inhibition of specific biomarkers to modify keratoconus disease progression

Condition

Keratoconus

Intervention

Cyclosporins

Study Arms / Comparison Groups

 Controls, Keratoconus
Description:  Sub group of Keratoconus to be treated with anti-inflammatory agents ie Cyclosporine-A

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

April 2013

Completion Date

December 2015

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Evidence of corneal thinning by any type of keratometry

        Exclusion Criteria:

          -  Corneal inflammation without evidence of ectasia

          -  Retinal disorder subjects excluded
      

Gender

All

Ages

10 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Rohit Shetty, MBBS,DNB, FRCS, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01746823

Organization ID

NNKC-2011


Responsible Party

Principal Investigator

Study Sponsor

Narayana Nethralaya

Collaborators

 Singapore Eye Research Institute

Study Sponsor

Rohit Shetty, MBBS,DNB, FRCS, Principal Investigator, Narayana Nethralaya


Verification Date

December 2012