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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2021-10-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Keratoconus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

eye rubbing questionnaire at baseline and 15 days later

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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exploratory phase

eye rubbing questionnaire at baseline and 15 days later

Group Type EXPERIMENTAL

eye rubbing questionnaire

Intervention Type OTHER

eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal

Interventions

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eye rubbing questionnaire

eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal

Intervention Type OTHER

Eligibility Criteria

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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