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OpenTrials
Completed

NCT Number: NCT07800975

Keratoconus - Screening in Patients With Downs Syndrome

The initial purpose of the study is to determine the true tomographic based age-specific prevalence of keratoconus among Danish patients with Downs Syndrome.

If, as expected, the prevalence is sizeable, the next step is to determine the optimal age for screening - considering both sensitivity and specificity as well as the need for early diagnosis in order to preserve a good visual acuity with glasses.

Lastly, the overall purpose based on the finding in the study is to evaluate if a tomographic screening program for keratoconus among patients with Downs syndrome is beneficial in Denmark.

In addition, a sub-study will further have the purpose to investigate whether patients with Downs syndrome are using optimal correction. With the purpose of generating knowledge about refraction of this specific patient group - independent of whether they are diagnosed with keratoconus or not.

The study will invite all persons with a genetic test either prenatal or postnatal showing trisomi 21 / Downs syndrom in Denmark and between the age og 10 and 20 years of age.

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Key information

Conditions

Tomography Eye Diseases Refraction Error Refractive Errors Visual Acuity

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • genetic diagnosis of trisomi 21 / downs syndrome

Exclusion criteria

  • inability to have cornea tomography performed

Treatment and study plan

Primary outcomes

  1. Corneal tomography

    Time frame: Baseline, single time point when the study participants are included in the study

    Corneal tomography to determine if the participant has keratoconus or not

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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