The K-Map Study, Global Prevalence of KC

August 6, 2025 updated by: Farhad Hafezi, University Hospital, Geneva

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 23 years (Child, Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of keratoconus
Time Frame: 15 minutes
Number of keratoconus cases detected
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

ELZA Institute

Investigators

  • Study Director: Farhad Hafezi, ELZA Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2015

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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