The K-Map Study, Global Prevalence of KC

Part of paid clinical trials in Los Angeles, California.

Sponsor
University Hospital, Geneva
Study ID
NCT03115710
Status
Recruiting
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Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
6 Years - 23 Years
Healthy Volunteers
Accepted

Interventions

  • Rotating Scheimpflug camera (Pentacam HR) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Dec 28, 2015
Status verified
Aug 2025
Primary completion
Feb 1, 2030
Completion
Feb 1, 2030

Study Design

Enrollment
20,000 participants (estimated)

Primary Outcome Measure

Prevalence of keratoconus [ Time Frame: 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USC Roski Eye InstituteLos AngelesCalifornia90033
J. Bradley Randleman, MD

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USC Roski Eye Institute· Los Angeles, CA

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