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COMPLETED
NCT07800975

Keratoconus - Screening in Patients With Downs Syndrome

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

10 Years - 20 Years

Study Type

OBSERVATIONAL

Enrollment

137

Start Date

2025-09-15

Completion Date

2026-06-01

Last Updated

2026-09-02

Healthy Volunteers

No

Locations (1)

Aarhus University Hospital

Aarhus, Denmark