Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    470
  • sponsor
    University Hospital, Bordeaux
Updated on 4 April 2021

Summary

KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.

Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.

Description

CNRK center is working on an eye rubbing questionnaire since 2017 in order to quantify that pejorative factor. Patient education can limit in a certain amount the Keratoconus progression. Thus, our objective will be to evaluate the therapeutic impact on Keratoconus progression of patient's education against eye rubbing according to an eye rubbing Questionnaire.

The validation of a dedicated questionnaire is an important act that will allow the scientific evaluation of this factor with both environmental and behavioral traits. It can thus be integrated into our care activity for its intrinsic educational and therapeutic virtues and for its decision-making aid for certain treatments. It will be useful first of all for the refinement of the correct prescription of corneal collagen crosslinking for evolving KC or KC with a high risk of progression.

Details
Condition Keratoconus
Treatment eye rubbing questionnaire
Clinical Study IdentifierNCT04517903
SponsorUniversity Hospital, Bordeaux
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Coming for the first time for expert advice on KC
Having a suspected or known KC
Being over 13 years old (or from 13 years old)
Possess computer connection equipment (computer, tablet or smartphone) and access to the network, for the completion of the questionnaire at home
Being affiliated to or beneficiary of health insurance
Have signed the informed consent form from the patient and from legal representatives for minor patient

Exclusion Criteria

Being incapacitated or unable to follow study procedures
Patient under legal protection
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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