NCT06058637

Brief Summary

The aim of this study is to investigate the cost-effectiveness of a nurse-assisted online eye-screening in home healthcare in reducing eye complaints.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

July 3, 2023

Last Update Submit

December 16, 2025

Conditions

Eye Diseases

Keywords

Eye screeningElderlyHome healthcareVisual impairmentCluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Colenbrander-1M visual acuity

    Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart

    12 months

Secondary Outcomes (10)

  • Colenbrander-1M visual acuity change

    12 months

  • Colenbrander-1M visual acuity change in participants with baseline visual impairment

    12 months

  • Optometric status

    12 months

  • Vision related quality of life with the EyeQ questionnaire

    12 months

  • Amsler grid chart

    12 months

  • +5 more secondary outcomes

Other Outcomes (2)

  • Health care utilization with the Medical Cost Questionnaire

    12 months

  • Process evaluation: questionnaire based on both the RE-AIM framework and Telemonitoring Acceptance Framework

    6 months

Study Arms (2)

Care as usual

NO INTERVENTION

Eye screening on top of care

EXPERIMENTAL
Device: Eye screening

Interventions

Eye screeningDEVICE

Nurse-assisted eye-screening will take place with the Easee app, which is implemented on the tablet or laptop of the community nurse. The nurse's smartphone will function as a remote control by which he/she submits input to a computer screen that displays the test. If the participant can do the test by him or herself, the nurse will merely supervise to ensure correct application. Standard audio instructions guide the nurse and participant through the test. The test will start with triage questions, which are used to set up a correct referral. During the test, both eyes are tested consecutively, covering one eye at a time. The participant will wear his/her spectacles, if present. The participant is presented a sequence of optotypes (i.e. tumbling-E and triangle-circle optotypes) that the participant must correctly identify, in addition to various grate sizes, both near and at a distance. The Amsler grid test is performed to detect any macular problems.

Eye screening on top of care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients receive home healthcare for health problems
  • years or older
  • Understanding of the Dutch language
  • Cognitive ability to participate in research (six-item Mini Mental State Examination: score \>3)

You may not qualify if:

  • Very serious health condition of the patient (i.e. terminal illness, receiving palliative home care)
  • Cognitively unable to participate in research (e.g. late stage Alzheimer's/Dementia, Parkinson's) (six-item Mini Mental State Examination: score ≤3)
  • Having received an optometric or ophthalmic consultation within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

Location

Related Publications (1)

  • Rooth V, van der Aa H, Wisse RPL, Maarsingh OR, Koopmanschap M, Keunen JEE, Vermeulen H, Klaver CCW, Janssen G, van Rens GHMB, van Nispen RMA. Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial. Trials. 2024 Feb 2;25(1):102. doi: 10.1186/s13063-023-07882-0.

    PMID: 38308377DERIVED

MeSH Terms

Conditions

Eye DiseasesVision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruth van Nispen

    Amsterdam UMC - VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Research assistants who will perform the measurements after randomisation will be masked.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

July 3, 2023

First Posted

September 28, 2023

Study Start

March 23, 2023

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

NL(1)