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NCT Number: NCT07015034

Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • +70 years
  • One or more chronic diseases
  • Are followed by GP du to chronic disease

Exclusion criteria

  • Dementia diagnosis
  • Known eye-diseases or are currently followed by private ophtalmologist
  • Not able to understand Danish

Treatment and study plan

focus on vision impairment in older patients in general practice

Other

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.

Primary outcomes

  1. 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

  2. Adherence

    Time frame: From enrollment to completion of GP intervention within 3 weeks.

    Proportion of patients who complete the intervention elements in general practice.

  3. Adherence

    Time frame: From enrollment to completion of optometrist testing within 5 months.

    Proportion of patients completing vision tests in an optometrist setting.

  4. Acceptability

    Time frame: From enrollment to interview within 12 months.

    Patient and health providers experiences and acceptability of the DETECT intervention

Other outcomes

  1. GP staff assessment of patient vision pre- and post-the three vision tests compared with ophthalmologist evaluation

    Time frame: From enrollment to the ophthalmologist evaluation within 6 months.

    pre- and post test assessment by GP staff. Pre-test assessment is based on prehand knowledge of the patient and observations in the clinic before the DETECT vision tests post-test assessment is based on the results of the DETECT visiontests Both assessments are entered into a questionnaire through surveyXact

  2. Patient-reported assessment of vision in baseline questionnaire compared with ophthalmologist evaluation

    Time frame: From enrollment to the ophthalmologist evaluation within 6 months.

    Patient reported outcome measure compared with ophthalmologist evaluation

  3. Patients with vision reduction or signs of eye diseases detected at the vision tests by GP staff

    Time frame: From enrollment to completion of GP intervention within 3 weeks.

    • Reduced vision: The proportion of patients with binocular near visual acuity <0.7 (decimal value), assessed in a general practice setting using the Colenbrander near vision test while wearing habitual reading glasses.

    OR • Reduced contrast vision: The proportion with a difference of 4 or more lines between high-contrast and low-contrast Colenbrander near visual acuity with binocular vision. The normality cutoff defined as 2-3 lines difference.

    OR

    • Central visual defects indicating macular pathology e.g. wet AMD: The proportion of patients with a positive Amsler grid test, tested monocular.

    OR • Peripheral vision loss indicating e.g. glaucoma: The proportion of patients with abnormal findings on confrontational visual field testing, tested monocular.

    OR

    • Indication of reduced vision or eye disease: The proportion of patients with at least one of the above
  4. Ophthalmologist assessment of potential benefit of new distance correction or need for ophthalmological review and possible treatment

    Time frame: From optometrist testing to ophthalmologist evaluation within 4 weeks.

    The proportion of patients for whom the ophthalmologist, based on data provided by the optometrist, assessed that a new distance correction would provide clinical benefit. Benefit was defined as an improvement of more than two lines in visual acuity, with a baseline binocular distance visual acuity <0.7. This includes the proportion of included patients requiring ophthalmological follow-up and possible treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Catharina Thiel Sandholdt, phd

CONTACT

[email protected]

+4531646460

Frans Boch Waldorff, prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice (DETECT)

Acronym: DETECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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