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RecruitingNCT03115710Updated Aug 11, 2025

The K-Map Study, Global Prevalence of KC

An observational study in Keratoconus, sponsored by University Hospital, Geneva. Recruiting at 12 sites in 12 countries. Open to participants aged 6 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
6 Years to 23 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratoconus

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Keywords

  • Keratoconus
  • Prevalence
03

Who can participate

Ages eligible
6 Years to 23 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

Exclusion Criteria:

  • Patients with a preexisting ocular disease / condition
  • Pregnancy or breastfeeding
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Patient registry
No

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.

05

What researchers measure

Primary outcomes

  1. Prevalence of keratoconus

    Number of keratoconus cases detected

    Time frame: 15 minutes

06

Study locations

10 of 12 sites recruiting
  • USC Roski Eye Institute
    Los Angeles, California 90033, United States
    • J. Bradley Randleman, MD · Contact
    Recruiting
  • Eye Hospital of Wenzhou Medical College
    Wenzhou, China
    • Shihao Chen, MD MSC · Contact
    Recruiting
  • Zagreb, Croatia
    Recruiting
  • Alexandria, Egypt
    Recruiting
  • Homburg, Germany
    Recruiting
  • Isfahan, Iran
    Recruiting
  • Amman, Jordan
    Recruiting
  • Monterrey, Mexico
    Recruiting
  • Lima, Peru
    Recruiting
  • Ufa Eye Research Intitute
    Ufa, Russia
    Completed
  • King Saud University
    Riyadh, Saudi Arabia
    Completed
  • Bukhara, Uzbekistan
    Recruiting
07

References and documents

Publications

  • 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. PubMed 29298777 ↗
08

Registry details

Key details

Study ID
NCT03115710
Lead sponsor
University Hospital, Geneva
Collaborators
ELZA Institute
Responsible party
Farhad Hafezi (MDPhD, University Hospital, Geneva) — Principal investigator
First posted
Apr 14, 2017
Start date
Dec 28, 2015
Primary completion
Feb 1, 2030 (estimated)
Completion
Feb 1, 2030 (estimated)
Last update
Aug 11, 2025

Study contacts

Farhad Hafezi, MDPhD
Contact
fhafezi@elza-institute.com
+41 44 741 81 81
Farhad Hafezi
study director · ELZA Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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