The K-Map Study, Global Prevalence of KC

Keratoconus Clinical Trial

Official title:

The K-Map Study, Global Prevalence of KC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03115710
• Other study ID #: CR-09
• Status: Recruiting
• Start date: December 28, 2015
• Est. completion date: February 1, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: Farhad Hafezi, MDPhD
• Phone: +41 44 741 81 81
• Email: fhafezi[@]elza-institute.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Diagnostic Test:
• Rotating 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.

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou
Saudi Arabia	King Saud University	Riyadh
United States	USC Roski Eye Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	ELZA Institute

Countries where clinical trial is conducted

United States,  China,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of keratoconus	Number of keratoconus cases detected	15 minutes