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

Keratoconus Clinical Trial

— QFK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517903
• Other study ID #: CHUBX 2019/53
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: October 13, 2021

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• eye rubbing questionnaire
eye rubbing questionnaire

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	CHU de Clermont-Ferrad	Clermont-Ferrand
France	Hospices Civils de Lyon	Lyon
France	CHU de Montpellier	Montpellier
France	Centre National Ophtalmologique des Quinze Vingt	Paris
France	CHU de Rouen	Rouen
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline and 6 months after (Month 6)
Secondary	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	Baseline and Month 6
Secondary	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)	Baseline and Month 6