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

Primary Purpose

Keratoconus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
eye rubbing questionnaire
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratoconus focused on measuring Keratoconus, Eye rubbing

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU BordeauxRecruiting
  • CHU Brest
  • CHU de Clermont-Ferrad
  • Hospices Civils de Lyon
  • CHU de Montpellier
  • Centre National Ophtalmologique des Quinze Vingt
  • CHU de Rouen
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

exploratory phase

Confirmatory phase

Arm Description

eye rubbing questionnaire at baseline and 15 days later

eye rubbing questionnaire at baseline and at 6 month follow-up

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

impact of the questionnaire on the reduction or cessation of eye rubbing
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
Monitoring the scability of the KC from clinical data
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
Estimate the scalability of the KC at 6 months
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)

Full Information

First Posted
August 14, 2020
Last Updated
December 26, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04517903
Brief Title
Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
Acronym
QFK
Official Title
Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Eye rubbing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exploratory phase
Arm Type
Experimental
Arm Description
eye rubbing questionnaire at baseline and 15 days later
Arm Title
Confirmatory phase
Arm Type
Experimental
Arm Description
eye rubbing questionnaire at baseline and at 6 month follow-up
Intervention Type
Other
Intervention Name(s)
eye rubbing questionnaire
Intervention Description
eye rubbing questionnaire
Primary Outcome Measure Information:
Title
validation of our eye rubbing questionnaire
Description
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)
Secondary Outcome Measure Information:
Title
impact of the questionnaire on the reduction or cessation of eye rubbing
Description
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
Time Frame
Baseline and 6 months after (Month 6)
Title
Monitoring the scability of the KC from clinical data
Description
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
Time Frame
Baseline and Month 6
Title
Estimate the scalability of the KC at 6 months
Description
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)
Time Frame
Baseline and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Touboul, MD-PhD
Phone
+335 56 79 55 30
Email
david.touboul@chu-bordeaux.fr
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Touboul, MD, PhD
Phone
+335 56 79 55 30
Email
david.touboul@chu-bordeaux.fr
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice Cochener, MD, PhD
Phone
+332 98 22 34 40
Email
beatrice.cochener@ophtalmologie-chu29.fr
Facility Name
CHU de Clermont-Ferrad
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic chiambaretta, MD, PhD
Phone
+334 73 75 14 67
Email
fchiambaretta@chu-clermontferrand.fr
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Burillon, MD, PhD
Phone
+334 78 86 14 00
Email
carole.burillon@chu-lyon.fr
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Daien, MD, PhD
Phone
+334 67 33 69 66
Email
v.daien@chu-montpellier.fr
Facility Name
Centre National Ophtalmologique des Quinze Vingt
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Borderie, MD, PhD
Phone
+331 40 02 15 11
Email
vborderie@15-20.fr
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Muraine, Md, PhD
Phone
+332 32 88 89 90
Email
marc.muraine@chu-rouen.fr
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Fournié, MD, PhD
Phone
+335 61 77 20 57
Email
fournie.p@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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