Keratoconus - Screening in Patients With Downs Syndrome
Key facts
- Who runs it
- University of Aarhus
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 137 people enrolled
- Started
- 15 Sept 2025
- Ended
- 1 Jun 2026
- Type of study
- Observational
- Record updated
- 2 September 2026
Who can take part
- Age
- 10 years to 20 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- genetic diagnosis of trisomi 21 / downs syndrome
Who cannot take part
- inability to have cornea tomography performed
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The initial purpose of the study is to determine the true tomographic based age-specific prevalence of keratoconus among Danish patients with Downs Syndrome.
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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.
The group in the trial
- Persons with Trisomi 21 / Downs syndrom, 10-20 years of age
The group is identified based on genetic testing either prenatal or postnatal
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 September 2026