Recruiting

Observational Study

Sponsor:

University Hospital, Geneva

Code:

NCT03115710

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 6 - 23

Healthy Volunteers: Accepted

Interventions

Rotating Scheimpflug camera (Pentacam HR)

Study Details

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.

Conditions

Keratoconus

Study ID

NCT03115710

Start date

Dec 28, 2015

Status verified date

Aug, 2025

Completion date

Feb 1, 2030

Anticipated

Primary completion date

Feb 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 23

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Prevalence of keratoconus [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Farhad Hafezi, MDPhD

+41 44 741 81 81fhafezi@elza-institute.com

Locations

USC Roski Eye Institute

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University Hospital, Geneva

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • Keratoconus
  • Prevalence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital, Geneva on 2025-08-11.