The K-Map Study, Global Prevalence of KC
1 other identifier
observational
20,000
12 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
August 11, 2025
August 1, 2025
14.1 years
April 10, 2017
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of keratoconus
Number of keratoconus cases detected
15 minutes
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients with a preexisting ocular disease / condition
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- ELZA Institutecollaborator
Study Sites (12)
USC Roski Eye Institute
Los Angeles, California, 90033, United States
Eye Hospital of Wenzhou Medical College
Wenzhou, China
Unknown Facility
Zagreb, Croatia
Unknown Facility
Alexandria, Egypt
Unknown Facility
Homburg, Germany
Unknown Facility
Isfahan, Iran
Unknown Facility
Amman, Jordan
Unknown Facility
Monterrey, Mexico
Unknown Facility
Lima, Peru
Ufa Eye Research Intitute
Ufa, Russia
King Saud University
Riyadh, Saudi Arabia
Unknown Facility
Bukhara, Uzbekistan
Related Publications (1)
Torres Netto EA, Al-Otaibi WM, Hafezi NL, Kling S, Al-Farhan HM, Randleman JB, Hafezi F. Prevalence of keratoconus in paediatric patients in Riyadh, Saudi Arabia. Br J Ophthalmol. 2018 Oct;102(10):1436-1441. doi: 10.1136/bjophthalmol-2017-311391. Epub 2018 Jan 3.
PMID: 29298777BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Farhad Hafezi
ELZA Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MDPhD
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 14, 2017
Study Start
December 28, 2015
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share