Keratoconus - Screening in Patients With Downs Syndrome

August 31, 2026 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Aarhus, Denmark, 8200
    - Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All persons with Downs syndrom in the relevant agegroup living in Denmark will be invited to the study

Description

Inclusion Criteria:

genetic diagnosis of trisomi 21 / downs syndrome

Exclusion Criteria:

inability to have cornea tomography performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Persons with Trisomi 21 / Downs syndrom, 10-20 years of age The group is identified based on genetic testing either prenatal or postnatal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, single time point when the study participants are included in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

Principal Investigator: Sashia Bennett, MD, PhD, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Actual)

June 1, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)