NCT02571647

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 11, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2017

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

October 5, 2015

Last Update Submit

May 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with presence of an ophthalmological disease (symptomatic or not) after clinical evaluation.

    6 month

Interventions

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).

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gilles BERRUT, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 8, 2015

Study Start

January 11, 2016

Primary Completion

April 24, 2017

Study Completion

April 24, 2017

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations