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

NCT04517903 | Completed

• 1 other identifier: CHUBX 2019/53
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 8

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.

Conditions

Keratoconus

Keywords

Keratoconus; Eye rubbing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• questionnaire simplification

  Month 6

• Expert consensus by nominal group

  Month 6

Study Arms (1)

exploratory phase

EXPERIMENTAL

eye rubbing questionnaire at baseline and 15 days later

Other: eye rubbing questionnaire

Interventions

eye rubbing questionnaire OTHER

eye rubbing questionnaire at baseline and 15 days later for exploratory phase; at baseline and then validation by a Group Nominal

exploratory phase

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being incapacitated or unable to follow study procedures
• Patient under legal protection
• Previous ocular surgery

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (8)

CHU Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

CHU de Clermont-Ferrad

Clermont-Ferrand, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

Centre National Ophtalmologique des Quinze Vingt

Paris, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: eye rubbing questionnaire at baseline and 15 days later

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 19, 2020
• Study Start: March 16, 2021
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)