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Life From Vision in Alzheimer Disease (VIVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00838942
First received: February 6, 2009
Last updated: October 27, 2011
Last verified: June 2011
History of Changes
  Purpose

The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.


Condition Intervention
Alzheimer Disease
Cataract
 Behavioral: Questionaries

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Improvement score of the NPI (Neuropsychiatric Inventory). The improvement is based on the increase by 1 point on the score of NPI [ Time Frame: 3 month after cataract surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement score of MMS(Mini mental status), of ADAS-COG(Alzheimer disease Assessment scale for cognitive function), IADL(Instrumental activity on daily) and GDS(Geriatric depression scale). [ Time Frame: 3 month after cataract surgery ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2004
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract.
 Behavioral: Questionaries
MMS (Mini Mental Status), ADAS-cog Alzheimer Disease Assessment Scale for cognitive functions, NPI (Neuropsychiatric Inventory) for behavior troubles, IADL (Instrumental Activities of Daily) for autonomy evaluation, GDS (Geriatric Depression Scale) or Cornell Scale (Cornell Scale for Depression in Dementia) for mood troubles.
Other Name: Questionaries

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract

Criteria

Inclusion Criteria:

  • Signed informed patient's or representative consent for the study
  • Patients over 50 years old
  • Patients whose bilateral visual acuity is less than 5/10, requiring cataract surgery
  • Patients suffering from Alzheimer's disease whose MMS score test is between 10 and 25 (10<MMS≤25)

Exclusion Criteria:

  • Patient's or representative's refusal
  • NEURO-ocular disease resulting in a severe vision impairment
  • Severe and evolving disease involving vital prognosis at short term
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838942

Locations
France
Hopital Tenon, Service Ophtalmologie
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Brigitte GIRARD, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00838942     History of Changes
Other Study ID Numbers: P 010110
Study First Received: February 6, 2009
Last Updated: October 27, 2011
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Eyes disease and dementia.
Cataract surgery in the patient with dementia.
Visual hallucinations
Visual acuity,
Specific eye pathologies in Alzheimer's disease.
 Improvement of behaviour,
Improvement of autonomy
Improvement of mood
Cataract extraction in Alzheimer disease patient

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Lens Diseases
Eye Diseases
Cataract
Dementia
Tauopathies

ClinicalTrials.gov processed this record on May 21, 2013