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RecruitingNCT03115710Updated Aug 11, 2025

The K-Map Study, Global Prevalence of KC

An observational study in Keratoconus, sponsored by University Hospital, Geneva. Recruiting at 12 sites in 12 countries. Open to participants aged 6 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by University Hospital, Geneva · Observational

From the registry’s dates

  • Started Dec 2015; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
6 Years to 23 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratoconus

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Keywords

  • Keratoconus
  • Prevalence
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 130 across 97 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 23 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with a preexisting ocular disease / condition
  • Pregnancy or breastfeeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testRotating 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.

06

What researchers measure

Primary outcomes

  1. Prevalence of keratoconus

    Number of keratoconus cases detected

    Time frame: 15 minutes

07

Study locations

10 of 12 sites recruiting
  • USC Roski Eye Institute
    Los Angeles, California 90033, United States
    Recruiting
    • J. Bradley Randleman, MD · Contact
  • Eye Hospital of Wenzhou Medical College
    Wenzhou, China
    Recruiting
    • Shihao Chen, MD MSC · Contact
  • Zagreb, Croatia
    Recruiting
  • Alexandria, Egypt
    Recruiting
  • Homburg, Germany
    Recruiting
  • Isfahan, Iran
    Recruiting
  • Amman, Jordan
    Recruiting
  • Monterrey, Mexico
    Recruiting
  • Lima, Peru
    Recruiting
  • Ufa Eye Research Intitute
    Ufa, Russia
    Completed

    Not enrolling at this site.

  • King Saud University
    Riyadh, Saudi Arabia
    Completed

    Not enrolling at this site.

  • Bukhara, Uzbekistan
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2015 (actual). Primary completion is estimated for Feb 2030, 169 months after the start.

Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 169 months is above that.

Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
Apr 14, 2017
StartActual
Dec 28, 2015
Primary completionEst.
Feb 1, 2030
CompletionEst.
Feb 1, 2030
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03115710
Collaborators
ELZA Institute
Responsible party
Farhad Hafezi (MDPhD, University Hospital, Geneva) — Principal investigator
First posted
Apr 14, 2017
Start date
Dec 28, 2015
Primary completion
Feb 1, 2030 (estimated)
Completion
Feb 1, 2030 (estimated)
Last update
Aug 11, 2025

Study contacts

Farhad Hafezi, MDPhD
Contact
fhafezi@elza-institute.com
+41 44 741 81 81
Farhad Hafezi
study director · ELZA Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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