Vision Impairment and BlindnessDETECTNCT07015034
Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
A study testing focus on vision impairment in older patients in general practice in people with Vision Impairment and Blindness and Glaucoma, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Impairment and Blindness, Glaucoma, Age-Related Macular Degeneration
- What is being tested?
- focus on vision impairment in older patients in general practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 May 2024to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- +70 years
- One or more chronic diseases
- Are followed by GP du to chronic disease
Who cannot join
- Dementia diagnosis
- Known eye-diseases or are currently followed by private ophtalmologist
- Not able to understand Danish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Frans Boch Waldorff, prof contact
Denmark2 sites, 2 recruiting
- Recruiting
GP practices
Copenhagen, Capital Region
Catharina Thiel Sandholdt, 004531646460, casa@sund.ku.dk
- Recruiting
GP practices
Køge, Region Sjælland
Catharina Thiel Sandholdt, 004531646460, casa@sund.ku.dk
About this study
Official title: Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice (DETECT)
In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.
Read the detailed description
Introduction: The number of people living with visual impairment is increasing. Visual impairment causes loss in quality of life and reduce self-care abilities. The burden of disease is heavy for people experiencing visual impairment and their relatives. The severity and progression of age-related eye diseases are dependent on the time of detection and treatment options, making timely access to healthcare critical in reducing visual impairment. General practice plays a key role in public health by managing preventive healthcare, diagnostics and treatment of chronic conditions. General practitioners (GPs) coordinate services from other healthcare professionals. More involvement of the primary sector could potentially be valuable in detecting visual impairment.
Methods: Investigators apply the Medical Research Council framework for complex interventions to develop a primary care intervention with the GP as a key actor, aimed at identifying and coordinating care for patients with low vision. The development process will engage patients, relatives and relevant health professional stakeholders. The investigators will pilot test the feasibility of the intervention in a real-world general practice setting. The intervention model will be developed through a participatory approach using qualitative and creative methods such as graphical facilitation. The project aims to explore the potentials and limitations of general practice in relation to detection of preventable vision loss.
Ethics and dissemination: Ethics approval is obtained from local authority and the study meets the requirements from the Declaration of Helsinki. Dissemination is undertaken through research papers and to the broader public through podcasts and patient organisations.
- Conditions
- Vision Impairment and Blindness, Glaucoma, Age-Related Macular Degeneration, Cataract, Diabetic Retinopathy
- Being tested
- focus on vision impairment in older patients in general practice
- Medical subject headings
- Vision Disorders, Blindness, Glaucoma, Macular Degeneration, Cataract, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus on vision impairment in older patients in general practiceOther
GP or GP nurse carry out the three vision tests. All patients visit optician shop collaborating with the project. An ophthalmologist review data from optometrists and provide an epicrisis to general practice. In case of acute conditions, the ophthalmologist is responsible for expedient treatment. If the patient needs further control by ophthalmologist within 12 month waiting time, general practice are responsible for referring the patient.
| Study group | Role | What they receive |
|---|---|---|
| Three vision tests in general practice | Other | All patients recruited in general practice are asked to fill out a patient questionnaire and examined:
- Collenbrander Mixed contrast card: testing near vision binocularly at 40 cm, using both 100% and 10% contrast.
- Amsler Test: Conducted for both eyes to check for central vision issues.
- Visual Field Test: Performed using the Donders method to assess peripheral vision, conducted for both eyes.
After tests in general practice, all patients undergo a comprehensive vision assessment at local optician shops, which include the following tests:
* Habitual Vision Testing: Near and distance vision with habitual glasses.
* Best Corrected Distance Vision: Monocular and binocular.
* Intraocular Pressure Measurement Assessed using air tonometry or Icare.
* Ocular Imaging: 3D peripapillary and macula optical coherence tomography (OCT) scans, and fundus photography.
A project ophtalmologist analyze patient-data from optometrists. Receives: Other: focus on vision impairment in older patients in general practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Total number of patients invited to participate in the study based on the exclusion sheet and the proportion of eligible patients included by GP staff
Measured: From invitation to participate to enrollment within 4 weeks
Adherence
Proportion of patients who complete the intervention elements in general practice.
Measured: From enrollment to completion of GP intervention within 3 weeks.
Adherence
Proportion of patients completing vision tests in an optometrist setting.
Measured: From enrollment to completion of optometrist testing within 5 months.
Acceptability
Patient and health providers experiences and acceptability of the DETECT intervention
Measured: From enrollment to interview within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 May 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vision Impairment and BlindnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharina Thiel Sandholdt, University of Copenhagen
- Investigators
- Frans B Waldorff, Principal investigator, Center for Almen Medicin, KU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015034
- Sponsor's protocol ID
- 869353
- Other IDs
- 869353
- Acronym
- DETECT
- Status last verified
- Apr 2026
- First submitted
- 20 May 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sandholdt CT, Jonsson ABR, Reventlow S, Bach-Holm D, Line K, Kolko M, Jacobsen MH, Mathiesen OH, Waldorff FB. DETECT: DEveloping and testing a model to identify preventive vision loss among older paTients in gEneral praCTice - protocol for a complex intervention in Denmark. BMJ Open. 2023 May 29;13(5):e069974. doi: 10.1136/bmjopen-2022-069974.
PubMed 37247966Brost AG, Petersen ML, Steinbo EKF, Siersma V, Bach-Holm D, Line K, Kristensen M, Waldorff FB, Sandholdt CT. Detection of age-related vision reduction in general practice in Denmark (DETECT): a study protocol for a feasibility and cohort study. BMJ Open. 2026 May 20;16(5):e115062. doi: 10.1136/bmjopen-2025-115062.
PubMed 42161554
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice (DETECT)
- ClinicalTrials.gov ID
- NCT07015034
- Acronym / sponsor ID
- DETECT / 869353
- Conditions
- Vision Impairment and Blindness, Glaucoma, Age-Related Macular Degeneration, Cataract, Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.
Detailed description
Introduction: The number of people living with visual impairment is increasing. Visual impairment causes loss in quality of life and reduce self-care abilities. The burden of disease is heavy for people experiencing visual impairment and their relatives. The severity and progression of age-related eye diseases are dependent on the time of detection and treatment options, making timely access to healthcare critical in reducing visual impairment. General practice plays a key role in public health by managing preventive healthcare, diagnostics and treatment of chronic conditions. General practitioners (GPs) coordinate services from other healthcare professionals. More involvement of the primary sector could potentially be valuable in detecting visual impairment.
Methods: Investigators apply the Medical Research Council framework for complex interventions to develop a primary care intervention with the GP as a key actor, aimed at identifying and coordinating care for patients with low vision. The development process will engage patients, relatives and relevant health professional stakeholders. The investigators will pilot test the feasibility of the intervention in a real-world general practice setting. The intervention model will be developed through a participatory approach using qualitative and creative methods such as graphical facilitation. The project aims to explore the potentials and limitations of general practice in relation to detection of preventable vision loss.
Ethics and dissemination: Ethics approval is obtained from local authority and the study meets the requirements from the Declaration of Helsinki. Dissemination is undertaken through research papers and to the broader public through podcasts and patient organisations.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three vision tests in general practice | Other | Other: focus on vision impairment in older patients in general practiceAll patients recruited in general practice are asked to fill out a patient questionnaire and examined: - Collenbrander Mixed contrast card: testing near vision binocularly at 40 cm, using both 100% and 10% contrast. - Amsler Test: Conducted for both eyes to check for central vision issues. - Visual Field Test: Performed using the Donders method to assess peripheral vision, conducted for both eyes. After tests in general practice, all patients undergo a comprehensive vision assessment at local optician shops, which include the following tests: * Habitual Vision Testing: Near and distance vision with habitual glasses. * Best Corrected Distance Vision: Monocular and binocular. * Intraocular Pressure Measurement Assessed using air tonometry or Icare. * Ocular Imaging: 3D peripapillary and macula optical coherence tomography (OCT) scans, and fundus photography. A project ophtalmologist analyze patient-data from optometrists. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- +70 years
- One or more chronic diseases
- Are followed by GP du to chronic disease
Key exclusion criteria (3 listed)
- Dementia diagnosis
- Known eye-diseases or are currently followed by private ophtalmologist
- Not able to understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focus on vision impairment in older patients in general practiceGP or GP nurse carry out the three vision tests. All patients visit optician shop collaborating with the project. An ophthalmologist review data from optometrists and provide an epicrisis to general practice. In case of acute conditions, the ophthalmologist is responsible for expedient treatment. If the patient needs further control by ophthalmologist within 12 month waiting time, general practice are responsible for referring the patient. | Other | Three vision tests in general practice |
Primary outcome
Recruitment feasibility
Time frame: From invitation to participate to enrollment within 4 weeks
Total number of patients invited to participate in the study based on the exclusion sheet and the proportion of eligible patients included by GP staff
Adherence
Time frame: From enrollment to completion of GP intervention within 3 weeks.
Proportion of patients who complete the intervention elements in general practice.
Adherence
Time frame: From enrollment to completion of optometrist testing within 5 months.
Proportion of patients completing vision tests in an optometrist setting.
Acceptability
Time frame: From enrollment to interview within 12 months.
Patient and health providers experiences and acceptability of the DETECT intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 37247966Sandholdt CT, Jonsson ABR, Reventlow S, Bach-Holm D, Line K, Kolko M, Jacobsen MH, Mathiesen OH, Waldorff FB. DETECT: DEveloping and testing a model to identify preventive vision loss among older paTients in gEneral praCTice - protocol for a complex intervention in Denmark. BMJ Open. 2023 May 29;13(5):e069974. doi: 10.1136/bmjopen-2022-069974.
- Derived from this study: PubMed 42161554Brost AG, Petersen ML, Steinbo EKF, Siersma V, Bach-Holm D, Line K, Kristensen M, Waldorff FB, Sandholdt CT. Detection of age-related vision reduction in general practice in Denmark (DETECT): a study protocol for a feasibility and cohort study. BMJ Open. 2026 May 20;16(5):e115062. doi: 10.1136/bmjopen-2025-115062.
- Individual participant dataSharing planned: Undecided
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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.
Frans Boch Waldorff, prof contact
Frans B Waldorff principal investigator
Center for Almen Medicin, KU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focus on vision impairment in older patients in general practice in people with Vision Impairment and Blindness and Glaucoma, run by University of Copenhagen at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catharina Thiel Sandholdt, phd (+4531646460, casa@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: From invitation to participate to enrollment within 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07015034, which also lists 2 linked publications.
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 31 Aug 2026.