The K-Map Study, Global Prevalence of KC

Recruiting

• Conditions: Keratoconus

• Registration Number: NCT03115710
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-28
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of keratoconus	15 minutes	Number of keratoconus cases detected

Trial Locations

Locations (3)

King Saud University; 🇸🇦 Riyadh, Saudi Arabia

Eye Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, China

USC Roski Eye Institute; 🇺🇸 Los Angeles, California, United States