The K-Map Study, Global Prevalence of KC

University Hospitals (UH)

Status: Enrolling

Conditions: Keratoconus

Treatments: Diagnostic Test: Rotating Scheimpflug camera (Pentacam HR)

Study type: Observational

Funder types: Other

Identifiers

NCT03115710

CR-09

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 6 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients with a preexisting ocular disease / condition
• Pregnancy or breastfeeding