The K-Map Study, Global Prevalence of KC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rotating Scheimpflug camera (Pentacam HR).
- Who it may be relevant to
- Registry conditions: Keratoconus. Basic parameters: 6 years — 23 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Croatia, Egypt, Germany +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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. Th
Primary outcome measures
- Prevalence of keratoconus [Time frame: 15 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- USC Roski Eye Institute — Los Angeles
China · 1 center
- Eye Hospital of Wenzhou Medical College — Wenzhou
Croatia · 1 center
- Center not named — Zagreb
Egypt · 1 center
- Center not named — Alexandria
Germany · 1 center
- Center not named — Homburg
Iran · 1 center
- Center not named — Isfahan
Jordan · 1 center
- Center not named — Amman
Mexico · 1 center
- Center not named — Monterrey
Peru · 1 center
- Center not named — Lima
Russia · 1 center
- Ufa Eye Research Intitute — Ufa
Saudi Arabia · 1 center
- King Saud University — Riyadh
Uzbekistan · 1 center
- Center not named — Bukhara
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. PMID 29298777
Identifiers
NCT: NCT03115710 · CR-09