Eye DiseasesNCT06058637
iSCREEN-study: Online Nurse-assisted Eye-screening in Home Healthcare
A study testing Eye screening in people with Eye Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Eye screening
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2023to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients receive home healthcare for health problems
- 65 years or older
- Understanding of the Dutch language
- Cognitive ability to participate in research (six-item Mini Mental State Examination: score >3)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Nurse-assisted Eye-screening in Home Healthcare; Implementation Study and Economic Evaluation, From an Individual, Healthcare and Socio-political Perspective
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.
Read the detailed description
Background:
In the Netherlands, the prevalence of blindness and low vision is highest among the elderly in care institutions and in home healthcare (20-25%). A recent cross-sectional pilot study with one of the largest home healthcare organizations in the Netherlands (i.e. 'Buurtzorg Nederland') showed that simple eye-screening by community nurses helps to detect eye complaints among elderly people living independently. Of all patients who were referred to a general practitioner (GP), optician, optometrist or ophthalmologist based on this screening (20% of the total group), it was found that almost half had severe visual impairment, whereas others had eye complaints that had affected acuity to a smaller extent. In most cases, eye complaints could be treated with spectacles or cataract surgery, but also untreatable eye diseases were found. These complaints may not have been detected without eye-screening and treatment would not have been offered. Often, the elderly themselves or family/friends or care providers, do not recognize that their eyesight has decreased. However, this can negatively affect their quality of life and health status. To increase access to eye care the investigators will perform a study using an online eye screening, which can be performed by the community nurses or possibly the participants themselves in their home environment.
Purpose:
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.
Method:
The investigators will perform a cluster-RCT to compare online eye-screening guided by community nurses in addition to care as usual to a control condition, receiving only care as usual. It will be performed in collaboration with several home healthcare organizations. Measurements in both groups will take place at baseline, after 6 months and 12 months. This will include visual acuity measurements, questionnaires and an optometric examination.
This study will be conducted among 220 participants. Elderly clients, 65+, who receive home healthcare will be invited to participate. Clients who have a serious health condition, clients who are cognitively unable to participate, or clients who had received an optometric consultation within the last 6 months, will be excluded.
The eye-screening is developed by Easee and is CE marked. During the test, the visual acuity will be measured both near and at distance, and the Amsler grid test will be performed. The results of the eye-screening will be checked by an optometrist, and will be made available to the participant. This will be done by letter including a recommendation for a referral, if necessary.
- Conditions
- Eye Diseases
- Being tested
- Eye screening
- Keywords
- Eye screening, Elderly, Home healthcare, Visual impairment, Cluster randomized controlled trial
- Medical subject headings
- Eye Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Not described |
| Eye screening on top of care | Experimental | Not described Receives: Device: Eye screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colenbrander-1M visual acuity
Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart
Measured: 12 months
Secondary outcomes (10)
Colenbrander-1M visual acuity change
Average visual acuity change per eye in letters
Measured: 12 months
Colenbrander-1M visual acuity change in participants with baseline visual impairment
Number of participants with baseline visual impairment and clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity
Measured: 12 months
Optometric status
Optometric status assessed by slitlamp/fundusfotography
Measured: 12 months
Vision related quality of life with the EyeQ questionnaire
EyeQ questionnaire with 46 items. The items can be scored from "never" to always". EyeQ scores are expressed on a theta logit-scale from -4 (highest vision related quality of life) to +4 (lowest vision related quality of life).
Measured: 12 months
Amsler grid chart
The Amsler grid is a simple square containing a grid pattern and a dot in the middle. It is used to detect symptoms of macular degeneration. The chart is held at a distance of 30 cm. Single eye test will be done. A participant is asked to look at the central dot of the Amsler grid chart. In normal cases, the lines of the chart will be seen straight and parallel. 4 questions will be used to notice abnormalities such as distortion of lines, broken lines, missing lines and wavy lines.
Measured: 12 months
Fall and fracture calendar
Falling accidents and bone fractures will be assessed with a shortened version of the 'fall and fracture calendar'. A questionnaire with 6 questions on the number of falls and fractures during the last 6 months.
Measured: 12 months
Depressive symptomatology measured with the PHQ-9 questionnaire
9 questions corresponding to the Diagnostic Statistical Manual symptoms for major depressive disorder during the past 2 weeks. The PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: 12 months
Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire
EQ-5D-5L: covers the dimensions mobility, self-care, daily activities, pain and discomfort, and anxiety and depression. It contains a five response level: "no problems" to "not able to". Scores will be converted to a single utility index score using the value set of the Netherlands to obtain scores on a formative scale from 0 (lowest quality of life) to 1 (highest quality of life). The visual analog scale (VAS) is included for marking overall health today.
Measured: 12 months
Wellbeing with the ICEpop CAPability questionnaire
ICECAP-O: it measures five capability dimensions: attachment, security, role, enjoyment, and control. With one question per dimension. Each dimension can be scored on four levels. An overall score can range from 0 to 1, with higher scores indicating better capability.
Measured: 12 months
Health literacy with the European Health Literacy Survey Questionnaire
HLS-EU-Q: 16 items, they can be scored from "very easy" to "very difficult". Scoring varies between 0 and 16. Higher scores meaning more difficulty.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start23 Mar 2023
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Easee B.V.
- Responsible party
- Principal investigator, R.M.A. (Ruth) van Nispen, Amsterdam UMC, location VUmc
- Investigators
- Ruth van Nispen, Principal investigator, Amsterdam UMC - VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058637
- Sponsor's protocol ID
- NL78386.029.21
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38308377
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Nurse-assisted Eye-screening in Home Healthcare; Implementation Study and Economic Evaluation, From an Individual, Healthcare and Socio-political Perspective
- ClinicalTrials.gov ID
- NCT06058637
- Acronym / sponsor ID
- NL78386.029.21
- Conditions
- Eye Diseases
- Keywords
- Eye screening, Elderly, Home healthcare, Visual impairment, Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Easee B.V.
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 28 Sep 2023 (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.
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.
Detailed description
Background:
In the Netherlands, the prevalence of blindness and low vision is highest among the elderly in care institutions and in home healthcare (20-25%). A recent cross-sectional pilot study with one of the largest home healthcare organizations in the Netherlands (i.e. 'Buurtzorg Nederland') showed that simple eye-screening by community nurses helps to detect eye complaints among elderly people living independently. Of all patients who were referred to a general practitioner (GP), optician, optometrist or ophthalmologist based on this screening (20% of the total group), it was found that almost half had severe visual impairment, whereas others had eye complaints that had affected acuity to a smaller extent. In most cases, eye complaints could be treated with spectacles or cataract surgery, but also untreatable eye diseases were found. These complaints may not have been detected without eye-screening and treatment would not have been offered. Often, the elderly themselves or family/friends or care providers, do not recognize that their eyesight has decreased. However, this can negatively affect their quality of life and health status. To increase access to eye care the investigators will perform a study using an online eye screening, which can be performed by the community nurses or possibly the participants themselves in their home environment.
Purpose:
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.
Method:
The investigators will perform a cluster-RCT to compare online eye-screening guided by community nurses in addition to care as usual to a control condition, receiving only care as usual. It will be performed in collaboration with several home healthcare organizations. Measurements in both groups will take place at baseline, after 6 months and 12 months. This will include visual acuity measurements, questionnaires and an optometric examination.
This study will be conducted among 220 participants. Elderly clients, 65+, who receive home healthcare will be invited to participate. Clients who have a serious health condition, clients who are cognitively unable to participate, or clients who had received an optometric consultation within the last 6 months, will be excluded.
The eye-screening is developed by Easee and is CE marked. During the test, the visual acuity will be measured both near and at distance, and the Amsler grid test will be performed. The results of the eye-screening will be checked by an optometrist, and will be made available to the participant. This will be done by letter including a recommendation for a referral, if necessary.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | – |
| Eye screening on top of care | Experimental | Device: Eye screening |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients receive home healthcare for health problems
- 65 years or older
- Understanding of the Dutch language
- Cognitive ability to participate in research (six-item Mini Mental State Examination: score >3)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Eye screeningNurse-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. | Device | Eye screening on top of care |
Primary outcome
Colenbrander-1M visual acuity
Time frame: 12 months
Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart
10 secondary outcomes
Colenbrander-1M visual acuity change
Time frame: 12 months
Colenbrander-1M visual acuity change in participants with baseline visual impairment
Time frame: 12 months
Optometric status
Time frame: 12 months
Vision related quality of life with the EyeQ questionnaire
Time frame: 12 months
Amsler grid chart
Time frame: 12 months
Fall and fracture calendar
Time frame: 12 months
Depressive symptomatology measured with the PHQ-9 questionnaire
Time frame: 12 months
Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire
Time frame: 12 months
Wellbeing with the ICEpop CAPability questionnaire
Time frame: 12 months
Health literacy with the European Health Literacy Survey Questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Derived from this study: PubMed 38308377Rooth 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.
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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. This study is not recruiting at the moment.
Ruth van Nispen principal investigator
Amsterdam UMC - VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye screening in people with Eye Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 4 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colenbrander-1M visual acuity (time frame: 12 months). 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 NCT06058637, which also lists 1 linked publication.
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 23 Dec 2025.