NCT03115710 The K-Map Study, Global Prevalence of KC
| NCT ID | NCT03115710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Keratoconus |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2015-12-28 |
| Primary Completion | 2030-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2015-12-28 with a primary completion date of 2030-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Farhad Hafezi
STUDY DIRECTOR
ELZA Institute
Frequently Asked Questions
Who can join the NCT03115710 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 23 Years, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03115710 currently recruiting?
Yes, NCT03115710 is actively recruiting participants. Contact the research team at fhafezi@elza-institute.com for enrollment information.
Where is the NCT03115710 trial being conducted?
This trial is being conducted at Los Angeles, United States, Wenzhou, China, Zagreb, Croatia, Alexandria, Egypt and 8 additional locations.
Who is sponsoring the NCT03115710 clinical trial?
NCT03115710 is sponsored by University Hospital, Geneva. The principal investigator is Farhad Hafezi at ELZA Institute. The trial plans to enroll 20,000 participants.