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

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Other: eye rubbing questionnaire

• Registration Number: NCT04517903
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-19
• Study Start: 2021-03-16
• Primary Completion: 2021-10-13
• Study Completion: 2021-10-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
exploratory phase	eye rubbing questionnaire	eye rubbing questionnaire at baseline and 15 days later
Confirmatory phase	eye rubbing questionnaire	eye rubbing questionnaire at baseline and at 6 month follow-up

Primary Outcome Measures

Name	Time	Method
validation of our eye rubbing questionnaire	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

Name	Time	Method
Expert consensus by nominal group	Month 6	Expert consensus by nominal group. This is the only method suitable for validating a clinical questionnaire
questionnaire simplification	Month 6	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

Trial Locations

Locations (8)

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU Brest; 🇫🇷 Brest, France

CHU de Rouen; 🇫🇷 Rouen, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Centre National Ophtalmologique des Quinze Vingt; 🇫🇷 Paris, France

CHU de Clermont-Ferrad; 🇫🇷 Clermont-Ferrand, France

CHU de Montpellier; 🇫🇷 Montpellier, France