Life From Vision in Alzheimer Disease (VIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838942
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment
Alzheimer Disease Cataract Behavioral: Questionaries

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.
Study Start Date : December 2004
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838942

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

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00838942     History of Changes
Other Study ID Numbers: P 010110
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: June 2011

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
Neurocognitive Disorders
Mental Disorders
Lens Diseases
Eye Diseases