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

University Hospital of Bordeaux

Status: Completed

Conditions: Keratoconus

Treatments: Other: eye rubbing questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT04517903

CHUBX 2019/53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 292 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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292 participants in 1 patient group

exploratory phase

Experimental group

Description:

eye rubbing questionnaire at baseline and 15 days later

Treatment:

Other: eye rubbing questionnaire