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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03076606
Other study ID # AVIGE 16-114
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 20, 2017
Est. completion date May 4, 2020

Study information

Verified date January 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date May 4, 2020
Est. primary completion date May 4, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - at least 2 falls in the last 12 months, - applied in geriatric evaluation - talking French - affiliated to the social security system Exclusion Criteria: - not communicating - illiterate - Total blindness

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ophthalmologist examination
ophthalmologist examination after geriatric consultation

Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 day 1
Secondary new diagnosis or ophthalmologic pathology aggravation Percentage of patients in whom new diagnosis or ophthalmologic pathology aggravation was identified day 1
Secondary cognitive influence Compare the binocular visual acuity values agreement in each subgroup: with MMSE <18/30 and with MMSE =18/30 day 1
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