The K-Map Study, Global Prevalence of KC

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

6 year–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Hospital of Wenzhou Medical College, Wenzhou, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotating Scheimpflug camera (Pentacam HR)

Diagnostic Test

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.

Primary outcomes

Prevalence of keratoconus

Time frame: 15 minutes

Number of keratoconus cases detected

Study contacts

Contact information is provided by the study sponsor or research team.

Farhad Hafezi, MDPhD

CONTACT

[email protected]

+41 44 741 81 81

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

ELZA Institute

Registry information

Important dates

Study start: 2015
Primary completion: 2030
Study completion: 2030
First posted: Apr 14, 2017
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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