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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
292
eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal
CHU Bordeaux
Bordeaux, France
CHU Brest
Brest, France
CHU de Clermont-Ferrad
Clermont-Ferrand, France
Hospices Civils de Lyon
Lyon, France
CHU de Montpellier
Montpellier, France
Centre National Ophtalmologique des Quinze Vingt
Paris, France
CHU de Rouen
Rouen, France
CHU de Toulouse
Toulouse, France
validation of our eye rubbing questionnaire
validation of our eye rubbing questionnaire will be made through the evaluation of its Suitability (Appearance validity, Content validity), Reliability (Consistency and homogeneity, Reproducibility), Applicability (Feasibility and acceptability), Validity (Construct validity), Sensitivity (Sensitivity to change, Discriminative validity)
Time frame: Baseline and 15 days after (Day 15)
questionnaire simplification
Statistical criteria for questionnaire simplification: ceiling and floor effects, response rates, correlations, reproducibility, measurement error and internal consistency. These elements are part of the content validity and reliability stages of the COSMIN recommendations
Time frame: Month 6
Expert consensus by nominal group
Expert consensus by nominal group. This is the only method suitable for validating a clinical questionnaire
Time frame: Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.