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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517903
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.


Condition or disease Intervention/treatment Phase
Keratoconus Other: eye rubbing questionnaire Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and at 6 month follow-up for confirmatory phase and at home
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: exploratory phase
eye rubbing questionnaire at baseline and 15 days later
 Other: eye rubbing questionnaire
eye rubbing questionnaire
Experimental: Confirmatory phase
eye rubbing questionnaire at baseline and at 6 month follow-up
 Other: eye rubbing questionnaire
eye rubbing questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. validation of our eye rubbing questionnaire [ Time Frame: Baseline and 15 days after (Day 15) ]
    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)


Secondary Outcome Measures :
  1. impact of the questionnaire on the reduction or cessation of eye rubbing [ Time Frame: Baseline and 6 months after (Month 6) ]

    The evolution of the answers to the questionnaire and of the disease between the visit to M0 and the visit at 6 months will be defined by:

    • A decrease of at least one level in the intensity, or duration, or frequency of eye rubbing
    • Stopping eye rubbing

  2. Monitoring the scability of the KC from clinical data [ Time Frame: Baseline and Month 6 ]

    The clinical course being determined as follows:

    • Increase in maximum anterior or posterior keratometry (corneal curvature) of more than 1 diopter (D), or
    • Corneal thinning at the thinnest point of the cornea (CTP) of more than 10 microns

  3. Estimate the scalability of the KC at 6 months [ Time Frame: Baseline and Month 6 ]
    Estimate the scalability of the KC at 6 months for each of the rubbing categories (reduction of rubbing or not, cessation of rubbing or not)


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517903


Contacts
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Contact: David Touboul, MD-PhD +335 56 79 55 30 david.touboul@chu-bordeaux.fr

Locations
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France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: David Touboul, MD, PhD    +335 56 79 55 30    david.touboul@chu-bordeaux.fr   
CHU Brest Not yet recruiting
Brest, France
Contact: Beatrice Cochener, MD, PhD    +332 98 22 34 40    beatrice.cochener@ophtalmologie-chu29.fr   
CHU de Clermont-Ferrad Not yet recruiting
Clermont-Ferrand, France
Contact: Frederic chiambaretta, MD, PhD    +334 73 75 14 67    fchiambaretta@chu-clermontferrand.fr   
Hospices Civils de Lyon Not yet recruiting
Lyon, France
Contact: Caroline Burillon, MD, PhD    +334 78 86 14 00    carole.burillon@chu-lyon.fr   
CHU de Montpellier Not yet recruiting
Montpellier, France
Contact: Vincent Daien, MD, PhD    +334 67 33 69 66    v.daien@chu-montpellier.fr   
Centre National Ophtalmologique des Quinze Vingt Not yet recruiting
Paris, France
Contact: Vincent Borderie, MD, PhD    +331 40 02 15 11    vborderie@15-20.fr   
CHU de Rouen Not yet recruiting
Rouen, France
Contact: Marc Muraine, Md, PhD    +332 32 88 89 90    marc.muraine@chu-rouen.fr   
CHU de Toulouse Not yet recruiting
Toulouse, France
Contact: Pierre Fournié, MD, PhD    +335 61 77 20 57    fournie.p@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04517903    
Other Study ID Numbers: CHUBX 2019/53
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Keratoconus
Eye rubbing
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases