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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratoconus - Screening in Patients With Downs Syndrome
- ClinicalTrials.gov ID
- NCT07800975
- Acronym / sponsor ID
- 1-10-72-38-25
- Conditions
- Tomography, Visual Acuity, Refraction Error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Trisomi 21 / Downs syndrom, 10-20 years of age | – | –The group is identified based on genetic testing either prenatal or postnatal |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All persons with Downs syndrom in the relevant agegroup living in Denmark will be invited to the study
Key inclusion criteria (1 listed)
- genetic diagnosis of trisomi 21 / downs syndrome
Key exclusion criteria (1 listed)
- inability to have cornea tomography performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. We are not allowed to shared data on an individual level as per our ethical permission
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sashia Bennett, MD, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tomography and Visual Acuity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal tomography (time frame: Baseline, single time point when the study participants are included in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.