An interventional study of eye rubbing questionnaire in Keratoconus, sponsored by University Hospital, Bordeaux. Completed at 8 sites in France. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 292 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
eye rubbing questionnaire at baseline and 15 days later
Other: eye rubbing questionnaire
eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal
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
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux