The K-Map Study, Global Prevalence of KC
ConditionKeratoconus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-23
SponsorUniversity Hospital, Geneva
About this trial
Keratoconus is a ocular disease classified under ectatic diseases which often results in bilateral and asymmetrical corneal distortion. It usually affects patients at young age and can cause severe visual loss.
The overall goal of this study is to assess the prevalence of keratoconus (KC) in children and adolescents in various regions of the world based on modern tomographic imaging methods, and to verify whether the occurrence rates reported from literature should be corrected. Our hypothesis is that the prevalence of the disease is much higher than that traditionally reported.
At each site, corneal tomography examinations (Pentacam) will be performed bilaterally in children and adolescents, who are not ill or with any ophthalmological symptom. The population to be studied will be composed of children and adolescents on medical visits for non-ophthalmologic reasons, aged between 6 and 20 years. Multiple cities, from different continents (North America, South America, Asia and Europe) will participate.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female, 6-23 years of age.
Subjects seen for a non-ophthalmic appointment
Provide signed and dated patient consent form (signed by parents / legal guardians).
Willing to comply with all study procedures and be available for the duration of the study
Disqualifiers
Patients with a preexisting ocular disease / condition
Pregnancy or breastfeeding
Trial population
This project will include children and adolescent age (6 - 23).The rationale for selecting this age range is to detect the disease KC at early stages.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rotating Scheimpflug camera (Pentacam HR)
Diagnostic testOne visit to Ophthalmology Department is required from participant. Parents or legal guardians must attend with their child. The interview and test during visit take approximately 15 minutes. Interview includes filling out a questionnaire about risk factors of the disease and double check on understanding the consent form. The child will sit in front of the instrument (Pentacam HR Scheimpflug imaging system). The rotational measuring procedure generates Scheimpflug images in three dimensions. The images taken during the examination are digitalized, and all image data are transferred to the computer. It calculates a 3D virtual model of the anterior eye segment, from which all additional information is derived.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Prevalence of keratoconus
Number of keratoconus cases detected
Time frame
15 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Geneva
Lead sponsor
ELZA Institute
Collaborator
Source ClinicalTrials.gov