TomographyNCT07800975
Keratoconus - Screening in Patients With Downs Syndrome
An observational study of Tomography and Visual Acuity, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Tomography, Visual Acuity, Refraction Error
- How many people
- 137 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2025to 1 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All persons with Downs syndrom in the relevant agegroup living in Denmark will be invited to the study
Who may be able to join
- genetic diagnosis of trisomi 21 / downs syndrome
Who cannot join
- inability to have cornea tomography performed
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Corneal tomography
Corneal tomography to determine if the participant has keratoconus or not
Measured: Baseline, single time point when the study participants are included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Sep 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TomographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sashia Bennett, MD, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800975
- Sponsor's protocol ID
- 1-10-72-38-25
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not allowed to shared data on an individual level as per our ethical permission