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Correlation Between Eye Rubbing and Keratoconus Severity in a Treatment-naive Keratoconic Population (FROTT EYES)

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ClinicalTrials.gov Identifier: NCT02883881
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Study Description
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Brief Summary:
determination if, within a keratoconic population, strong eye rubbing was correlated with visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry, keratometry, and tomography classification determinating keratoconus stage.

Condition or disease
Keratoconus

Detailed Description:
A retrospective study was performed between november 2014 and october 2015 in the Metz Hospital Center. Were included 33 patients presenting with treatment-naive keratoconus. Patients responded to a questionnaire that assessed eye rubbing habits, family history of keratoconus, history of atopy. 2 groups were separated: group 1 constituted by 15 eyes with no eye rubbing, and group 2 constituted by 18 eyes with moderate or severe eye rubbing. The following informations were collected: best visual corrected acuity (BCVA), spherical equivalent value (SEV), corneal opacities or Vogt striae. For each eye were performed an anterior segment OCT (AS-OCT) to determine the OCT stage for keratoconus (Fourrier domain OCT classification, 2013), and a Scheimpflug camera imaging to determine the maximal keratometry (Kmax) and the minimal corneal thickness (MCT).
Study Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
No eye rubbing
with eye rubbing


Outcome Measures
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Primary Outcome Measures :
  1. visual acuity [ Time Frame: month 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presenting with treatment-naive keratoconus.
Criteria

Inclusion Criteria:

  • patients presenting with treatment-naive keratoconus.

Exclusion Criteria:

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02883881    
Other Study ID Numbers: 2015-02Obs-CHRMT
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases