Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2015-12-28
2030-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy or breastfeeding
6 Years
23 Years
ALL
Yes
Sponsors
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ELZA Institute
UNKNOWN
University Hospital, Geneva
OTHER
Responsible Party
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Farhad Hafezi
MDPhD
Principal Investigators
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Farhad Hafezi
Role: STUDY_DIRECTOR
ELZA Institute
Locations
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USC Roski Eye Institute
Los Angeles, California, United States
Eye Hospital of Wenzhou Medical College
Wenzhou, , China
Zagreb, , Croatia
Alexandria, , Egypt
Homburg, , Germany
Isfahan, , Iran
Amman, , Jordan
Monterrey, , Mexico
Lima, , Peru
Ufa Eye Research Intitute
Ufa, , Russia
King Saud University
Riyadh, , Saudi Arabia
Bukhara, , Uzbekistan
Countries
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Central Contacts
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Facility Contacts
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J. Bradley Randleman, MD
Role: primary
Shihao Chen, MD MSC
Role: primary
References
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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.
Other Identifiers
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CR-09
Identifier Type: -
Identifier Source: org_study_id
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