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The K-Map Study, Global Prevalence of KC

The K-Map Study, Global Prevalence of KC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03115710
Enrollment
20000
Registered
2017-04-14
Start date
2015-12-28
Completion date
2030-02-01
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, Prevalence

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.

Interventions

DIAGNOSTIC_TESTRotating 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.

Sponsors

ELZA Institute
CollaboratorUNKNOWN
University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 23 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of keratoconus15 minutesNumber of keratoconus cases detected

Countries

China, Croatia, Egypt, Germany, Iran, Jordan, Mexico, Peru, Russia, Saudi Arabia, United States, Uzbekistan

Contacts

Primary ContactFarhad Hafezi, MDPhD
fhafezi@elza-institute.com+41 44 741 81 81

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026