Visual DisordersEVAMNCT02571647
Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory
An observational study of Visual Disorders, run by Nantes University Hospital at 1 site in France.
Trial summary
Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Visual Disorders
- What is being tested?
- Non interventional study
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2016to 24 Apr 2017
- 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 eligible for the study will be all patients 65 and older, in consultation from memory or day hospital Clinical Gerontology ambulatory center at Nantes University Hospital. Geriatrician who will see the patient Clinical Gerontology ambulatory center be informed of the study and gather written consent and that of his legal representative, if applicable.
Who may be able to join
- Elderly over 65 years,
- Subject to consultation from memory Clinical Gerontology ambulatory center Nantes University Hospital
- Current use of spoken French
- Patient (or legal guardian, if applicable) has given its written consent
- Patient affiliated to a social security scheme
Who cannot join
- Life expectancy lower 1 year
- Mobility limitation preventing the installation retinal
- Major disorders and productive behavior does not allow participation in diagnostic procedures.
- Inability to respond to instructions when performing ophthalmological examinations.
Trial locations and contacts
1 site in 1 country.
About this study
Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.
- Conditions
- Visual Disorders
- Being tested
- Non interventional study
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Patients agreeing to participate in the study will have a cognitive assessment and geriatric assessment, carried out according to usual practices and grids clinical gerontology cluster.
They will benefit in addition to a noninvasive screening and risk-free ophthalmic (visual acuity, intraocular pressure, examination of the eyelids and fundus).
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with presence of an ophthalmological disease (symptomatic or not) after clinical evaluation.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start11 Jan 2016
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual DisordersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles BERRUT, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571647
- Sponsor's protocol ID
- RC15_0219
- Acronym
- EVAM
- Status last verified
- May 2019
- First submitted
- 5 Oct 2015
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory
- ClinicalTrials.gov ID
- NCT02571647
- Acronym / sponsor ID
- EVAM / RC15_0219
- Conditions
- Visual Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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.
Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.
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 eligible for the study will be all patients 65 and older, in consultation from memory or day hospital Clinical Gerontology ambulatory center at Nantes University Hospital. Geriatrician who will see the patient Clinical Gerontology ambulatory center be informed of the study and gather written consent and that of his legal representative, if applicable.
Key inclusion criteria (5 listed)
- Elderly over 65 years,
- Subject to consultation from memory Clinical Gerontology ambulatory center Nantes University Hospital
- Current use of spoken French
- Patient (or legal guardian, if applicable) has given its written consent
- Patient affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Life expectancy lower 1 year
- Mobility limitation preventing the installation retinal
- Major disorders and productive behavior does not allow participation in diagnostic procedures.
- Inability to respond to instructions when performing ophthalmological examinations.
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 |
|---|---|---|
| Non interventional studyPatients agreeing to participate in the study will have a cognitive assessment and geriatric assessment, carried out according to usual practices and grids clinical gerontology cluster. They will benefit in addition to a noninvasive screening and risk-free ophthalmic (visual acuity, intraocular pressure, examination of the eyelids and fundus). | Other | – |
Primary outcome
Number of participants with presence of an ophthalmological disease (symptomatic or not) after clinical evaluation.
Time frame: 6 month
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 10 May 2019.
Related trials for Visual Disorders
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
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.
Gilles BERRUT, Pr principal investigator
Nantes University Hospital
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 Disorders, run by Nantes University Hospital 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 5 inclusion and 4 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 10 May 2019. 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 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?
Number of participants with presence of an ophthalmological disease (symptomatic or not) after clinical evaluation. (time frame: 6 month). 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 10 May 2019.