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

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Other: eye rubbing questionnaire

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 Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Chu Bordeaux
  • Brest, France
    • CHU Brest
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrad
  • Lyon, France
    • Hospices Civils de Lyon
  • Montpellier, France
    • CHU de Montpellier
  • Paris, France
    • Centre National Ophtalmologique des Quinze Vingt
  • Rouen, France
    • CHU de Rouen
  • Toulouse, France
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exploratory phase; eye rubbing questionnaire at baseline and 15 days later	Other: eye rubbing questionnaire; eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 15 days after (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire simplification	Statistical criteria for questionnaire simplification: ceiling and floor effects, response rates, correlations, reproducibility, measurement error and internal consistency. These elements are part of the content validity and reliability stages of the COSMIN recommendations	Month 6
Expert consensus by nominal group	Expert consensus by nominal group. This is the only method suitable for validating a clinical questionnaire	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Keratoconus; Eye rubbing
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: CHUBX 2019/53; 2020-A00749-30 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No