KeratoconusNCT03115710
The K-Map Study, Global Prevalence of KC
An observational study of Keratoconus, run by University Hospital, Geneva at 12 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 6 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Rotating Scheimpflug camera (Pentacam HR)
- How many people
- 20,000 participants
- Where
- 12 sitesin 12 countries
- Study dates
- 28 Dec 2015to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This project will include children and adolescent age (6 - 23).The rationale for selecting this age range is to detect the disease KC at early stages.
Who may be able to join
- 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
Who cannot join
- Patients with a preexisting ocular disease / condition
- Pregnancy or breastfeeding
Trial locations and contacts
12 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 12 countries
United States1 site, 1 recruiting
- Recruiting
USC Roski Eye Institute
Los Angeles, California, 90033
J. Bradley Randleman, MD
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou
Shihao Chen, MD MSC
About this study
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.
- Conditions
- Keratoconus
- Being tested
- Rotating Scheimpflug camera (Pentacam HR)
- Keywords
- Keratoconus, Prevalence
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of keratoconus
Number of keratoconus cases detected
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start28 Dec 2015
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- ELZA Institute
- Responsible party
- Principal investigator, Farhad Hafezi, University Hospital, Geneva
- Investigators
- Farhad Hafezi, Study director, ELZA Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115710
- Sponsor's protocol ID
- CR-09
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2017
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29298777
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The K-Map Study, Global Prevalence of KC
- ClinicalTrials.gov ID
- NCT03115710
- Acronym / sponsor ID
- CR-09
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Prevalence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- ELZA Institute
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This project will include children and adolescent age (6 - 23).The rationale for selecting this age range is to detect the disease KC at early stages.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with a preexisting ocular disease / condition
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Prevalence of keratoconus
Time frame: 15 minutes
Number of keratoconus cases detected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Results publication: PubMed 29298777Torres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farhad Hafezi study director
ELZA Institute
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by University Hospital, Geneva at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, China, Croatia, Egypt, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farhad Hafezi, MDPhD (+41 44 741 81 81, fhafezi@elza-institute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of keratoconus (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.