An interventional study of focus on vision impairment in older patients in general practice in Vision Impairment and Blindness, Glaucoma and Age-Related Macular Degeneration, sponsored by University of Copenhagen. Recruiting at 2 sites in Denmark. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Screening
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.
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 460 is above the median of 37 across 101 interventional studies indexed under Blindness.
Browse Blindness studies →University of Copenhagen is the lead sponsor of 466 studies on the registry; 64 are open to participants now.
Compared within Blindness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vision Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: focus on vision impairment in older patients in general practice
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.
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
Time frame: From invitation to participate to enrollment within 4 weeks
Adherence
Proportion of patients who complete the intervention elements in general practice.
Time frame: From enrollment to completion of GP intervention within 3 weeks.
Adherence
Proportion of patients completing vision tests in an optometrist setting.
Time frame: From enrollment to completion of optometrist testing within 5 months.
Acceptability
Patient and health providers experiences and acceptability of the DETECT intervention
Time frame: From enrollment to interview within 12 months.
GP staff assessment of patient vision pre- and post-the three vision tests compared with ophthalmologist evaluation
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
Time frame: From enrollment to the ophthalmologist evaluation within 6 months.
Patient-reported assessment of vision in baseline questionnaire compared with ophthalmologist evaluation
Patient reported outcome measure compared with ophthalmologist evaluation
Time frame: From enrollment to the ophthalmologist evaluation within 6 months.
Patients with vision reduction or signs of eye diseases detected at the vision tests by GP staff
• 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
Time frame: From enrollment to completion of GP intervention within 3 weeks.
Ophthalmologist assessment of potential benefit of new distance correction or need for ophthalmological review and possible treatment
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
Time frame: From optometrist testing to ophthalmologist evaluation within 4 weeks.
Plan to share: Undecided
Started May 2024 (actual). Primary completion is estimated for Oct 2026, 29 months after the start.
Of 36 interventional studies with no phase under Blindness, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 19. This study's planned 29 months is below that.
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