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Keratoconus - Screening in Patients With Downs Syndrome

NCT07800975 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 137

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

  • Tomography
  • Visual Acuity
  • Refraction Error

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Sashia Bennett, MD, PhD · University of Aarhus

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800975 on ClinicalTrials.gov