Clinical trial NCT04517903: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
Official title: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Eye rubbing
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 292
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: eye rubbing questionnaire at baseline and 15 days later
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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
* Previous ocular surgery

Primary outcomes:
measure: validation of our eye rubbing questionnaire
timeFrame: Baseline and 15 days after (Day 15)
Secondary outcomes:
measure: questionnaire simplification
timeFrame: Month 6
measure: Expert consensus by nominal group
timeFrame: Month 6
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrad
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Centre National Ophtalmologique des Quinze Vingt
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: