Visual AcuityAVIGENCT03076606
Nurses Ability to Assess Visual Acuity in Geriatric Consultation
An observational study of Visual Acuity and Accidental Fall, run by University Hospital, Caen at 1 site in France.
Trial summary
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Visual Acuity, Accidental Fall, Aging
- What is being tested?
- ophthalmologist examination
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2017to 4 May 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Older adult
Study population: Patients aged 65 and over referred for Visual Acuity evaluation
Who may be able to join
- at least 2 falls in the last 12 months,
- applied in geriatric evaluation
- talking French
- affiliated to the social security system
Who cannot join
- not communicating
- illiterate
- Total blindness
Trial locations and contacts
1 site in 1 country.
About this study
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.
The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.
Read more
We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.
This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.
- Conditions
- Visual Acuity, Accidental Fall, Aging, Nurse's Role
- Being tested
- ophthalmologist examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmologist examinationDiagnostic test
ophthalmologist examination after geriatric consultation
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity values concordance between nurses and ophthalmologist
On 2 (near and far) binocular values per patient with their usual glasses. Concordance is assessed on the assignment of patients to one of the 3 groups: ≤ 5 / 10e, 6-7 / 10 e, ≥ 8/10 e
Measured: day 1
Secondary outcomes (2)
new diagnosis or ophthalmologic pathology aggravation
Percentage of patients in whom new diagnosis or ophthalmologic pathology aggravation was identified
Measured: day 1
cognitive influence
Compare the binocular visual acuity values agreement in each subgroup: with MMSE <18/30 and with MMSE ≥18/30
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start20 Mar 2017
- Primary completion4 May 2020
- Study completion4 May 2020
Why it stopped: recruiting issues and unavailable ophtalmologists
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076606
- Sponsor's protocol ID
- AVIGE 16-114
- Acronym
- AVIGE
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2017
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses Ability to Assess Visual Acuity in Geriatric Consultation
- ClinicalTrials.gov ID
- NCT03076606
- Acronym / sponsor ID
- AVIGE / AVIGE 16-114
- Conditions
- Visual Acuity, Accidental Fall, Aging, Nurse's Role
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting issues and unavailable ophtalmologists
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 10 Mar 2017 (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.
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.
The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.
We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.
This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and over referred for Visual Acuity evaluation
Key inclusion criteria (4 listed)
- at least 2 falls in the last 12 months,
- applied in geriatric evaluation
- talking French
- affiliated to the social security system
Key exclusion criteria (3 listed)
- not communicating
- illiterate
- Total blindness
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 |
|---|---|---|
| ophthalmologist examinationophthalmologist examination after geriatric consultation | Diagnostic test | – |
Primary outcome
visual acuity values concordance between nurses and ophthalmologist
Time frame: day 1
On 2 (near and far) binocular values per patient with their usual glasses. Concordance is assessed on the assignment of patients to one of the 3 groups: ≤ 5 / 10e, 6-7 / 10 e, ≥ 8/10 e
2 secondary outcomes
new diagnosis or ophthalmologic pathology aggravation
Time frame: day 1
cognitive influence
Time frame: day 1
Results and safety
The study was stopped early (reason given: recruiting issues and unavailable ophtalmologists). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity and Accidental Fall, run by University Hospital, Caen at 1 site in France.
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: stopped early, as of the sponsor's last update on 15 Sep 2023. 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 France. 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 was stopped early (reason given: recruiting issues and unavailable ophtalmologists). Results are not available in the source record.
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?
visual acuity values concordance between nurses and ophthalmologist (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2023.