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Keratoconus - Screening in Patients With Downs Syndrome

Keratoconus - Screening in Patients With Downs Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07800975
Enrollment
137
Registered
2026-09-02
Start date
2025-09-15
Completion date
2026-06-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refraction Error, Tomography, Visual Acuity

Brief 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.

Interventions

None listed

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* genetic diagnosis of trisomi 21 / downs syndrome

Exclusion criteria

* inability to have cornea tomography performed

Design outcomes

Primary

MeasureTime frameDescription
Corneal tomographyBaseline, single time point when the study participants are included in the studyCorneal tomography to determine if the participant has keratoconus or not

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORSashia Bennett, MD, PhD

University of Aarhus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026