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.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Diagnostic test: Rotating Scheimpflug camera (Pentacam HR)

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Farhad Hafezi, MDPhD; Phone Number: +41 44 741 81 81; Email: fhafezi@elza-institute.com

Study Locations

• China
  • Wenzhou, China
    • Recruiting
    • Eye Hospital of Wenzhou Medical College
    • Contact: Shihao Chen, MD MSC
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • King Saud University
    • Contact: Wafa Al Otaibi, MsC; Phone Number: 00966 553211482; Email: walotaibi@ksu.edu.sa
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Roski Eye Institute
      • Contact: J. Bradley Randleman, MD

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: ELZA Institute
• Investigators: Study Director: Farhad Hafezi, ELZA Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2015
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

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 (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Prevalence; Keratoconus
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: CR-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No