NCT03115710

The K-Map Study, Global Prevalence of KC

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 6 Years – 23 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rotating Scheimpflug camera (Pentacam HR)	One 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.

Timeline

• Start date: 2015-12-28
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2017-04-14
• Last updated: 2025-08-11

Locations

12 sites across 12 countries: United States, China, Croatia, Egypt, Germany, Iran, Jordan, Mexico, Peru, Russia, Saudi Arabia, Uzbekistan