What this study is
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.
What's being tested
- Rotating Scheimpflug camera (Pentacam HR)
Intervention · 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
- Sponsor
- University Hospital, Geneva
- Conditions
- Keratoconus
- Enrolling
- 20,000 people
- Starts
- 2015-12-28
- Est. completion
- 2030-02-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 23 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- Patients with a preexisting ocular disease / condition
- Pregnancy or breastfeeding
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
10 openUSC Roski Eye Institute
Los Angeles, California, United States
- J. Bradley Randleman, MD · Contact
Recruiting
11 sites outside the US
Eye Hospital of Wenzhou Medical College
Wenzhou, China
- Shihao Chen, MD MSC · Contact
RecruitingZagreb, Croatia
RecruitingAlexandria, Egypt
RecruitingHomburg, Germany
RecruitingIsfahan, Iran
RecruitingAmman, Jordan
RecruitingMonterrey, Mexico
RecruitingLima, Peru
RecruitingBukhara, Uzbekistan
RecruitingUfa Eye Research Intitute
Ufa, Russia
CompletedKing Saud University
Riyadh, Saudi Arabia
Completed
Study team
Sponsor
University Hospital, Geneva
Study ID CR-09
Study director
Farhad Hafezi
ELZA Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.