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

NCT07015034 | Recruiting DMC

• 1 other identifier: 869353
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

Brief 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 vision impairment at present time.

Conditions

Diabetic Retinopathy; Vision Impairment and Blindness; Glaucoma; Age-Related Macular Degeneration; Cataract

Outcome Measures

Primary Outcomes (4)

• 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

  From invitation to participate to enrollment within 4 weeks

• Adherence

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

  From enrollment to completion of GP intervention within 3 weeks.

• Adherence

  Proportion of patients completing vision tests in an optometrist setting.

  From enrollment to completion of optometrist testing within 5 months.

• Acceptability

  Patient and health providers experiences and acceptability of the DETECT intervention

  From enrollment to interview within 12 months.

Other Outcomes (4)

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

  From enrollment to the ophthalmologist evaluation within 6 months.

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

  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

  From enrollment to completion of GP intervention within 3 weeks.

Study Arms (1)

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.

Other: focus on vision impairment in older patients in general practice

Interventions

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.

Three vision tests in general practice

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (2)

GP practices

Copenhagen, Capital Region, Denmark

RECRUITING

GP practices

Køge, Region Sjælland, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 37247966 RESULT

MeSH Terms

Conditions

Vision Disorders; Blindness; Glaucoma; Macular Degeneration; Cataract; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Hypertension; Retinal Degeneration; Retinal Diseases; Lens Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Frans B Waldorff

  Center for Almen Medicin, KU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Thiel Sandholdt, phd

CONTACT

+4531646460; casa@sund.ku.dk

Frans Boch Waldorff, prof

CONTACT

fransw@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: GP's or GP nurses, optometrists and the project ophtalmologist all give their anamnesis (and potential diagnosis). Their anamnesis are blinded to each other
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 11, 2025
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (2)