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
  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:


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

  Hide Detailed Description

Detailed Description:

VIVA study aims to evaluate cataract surgery results on Alzheimer patients regarding behavior, autonomy and mood. Patients studied are elderly people suffering from both Alzheimer's disease and low vision due to a bilateral impeding cataract. Designed patients come from Ile-de-France-area geriatrics departments.

Methods: the trial consists in a series of neuropsychological tests involving both subject of the study and a close parent one-month before and three months after surgery of the most affected eye. Each patient is under investigation during 4+/1 months. The tests used are the 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. All data are registered along as well as medical treatments and severe side effects.

Practical method:An ophthalmologic surgery department head operates on the patients at National Ophthalmologic Hospital "QUINZE VINGT" in Paris.The surgery involves the eye with the worst vision. Study analysis does not take into account the results of the second eye intervention. The surgery consists in a phacoemulsification and setting of an acrylic implant in the posterior chamber. Patients care consists in the usual procedures. The intervention is performed under regional anesthesia exceptionally general anesthesia. A three-day hospitalization is regular considering patients' fragility.The aim of the study is to analyze 3 months after cataract surgery, the different neuropsychological tests, with the help of appropriate statistics. The main endpoint criterion will be the NPI-test improvement between the one-month test before surgery and the three-month test after. A correlation between visual acuity improvement and NPI-test improvement will be verified. The second endpoint criterion will be the study of other scores (MMS, IADL, ADAS-cog, GDS or Cornell test), in a matched-way. If improvement is noted, a regression logistic study will permit to study improvement predictive factors. Each participant will take part in the study during 4+/-1 months.Study rationale and literature data abstract.Cataract treatment, restoring a better visual function, is greatly beneficial upon life quality of elderly people, as largely demonstrated (1, 2). Several studies, based on cognitive functions, daily life activities, and mood, showed a significant amelioration of elderly people operated on for cataract, in comparison with those who refused the intervention (3). Benefice is less in case of ocular co morbidity or in some very old patients (4).Cataract surgery on elderly patients suffering from cognitive decline has given rise to very few studies. Nevertheless, correlation between low vision and cognitive alteration is well established. In France, a Health High Authority (HHA) report devoted to cataract surgical treatment evaluation, based on literature data and experts opinion, was published in 2000 (6). The report dealt with the taking in care of demented or low mental capacities patients. It regretted that very few trials were undertaken for this problem.. In case of beginning dementia, the experts thought that cataract surgery visual benefice is limited. It seldom improves lecture but allows patients to watch television more and makes contacts with neighbors easier. In case of advanced dementia, the authors thought that surgery would worsen rapidly patients. The report evoked as well the paternalistic decisions taken without any dialogue with the involved patient and raised ethical issues. Still to-day, in case of dementia, the cataract management remains an actual problem. This is a challenge for closes, guardians, geriatrics', ophthalmologists and sometimes the decision is opposed to patients' feelings (8).One of the studies cited in the HHA report, based on few low-vision patients, showed after cataract surgery, a light improvement of mental status, everyday life but poor results on depression. After surgery, patients felt that they were not as fragile as they had thought, that they endured the operation and felt better after (9). In 2003, a Japanese study dealt with cognitive functions of 40 demented patients suffering from cataract. Results and showed that among the 20 patients who chose to be operated on, 60% were improved, 35% were unchanged, and 5% worsened (10). By extensive neuropsychological investigations on Alzheimer' patients, the VIVA study would show the impact of visual function improvement on cognitive functions, psychological and behavioural troubles, autonomy, and mood perturbations. Pointing out the objectives upon improvement of neuropsychiatric survey, namely the NPI test, the study would permit to precise the low-vision cataract role on patients' comportment troubles which are a cause of burn-out for caring people. It is clearly demonstrated that delirious manifestations, notably visual hallucinations are frequent in demented persons and in patients with low vision as well (9). In low-vision patients, it seems that only the cataract is significantly linked to visual hallucinations (10). The VIVA study aims to show also the benefice of a better visual function on behavioural non-disturbing troubles such as apathy and inhibition. Therefore, we would like to stress the cataract management benefits on Alzheimer's disease patients. Particularly, we intend to precise the extent of expected patients' improvement and to measure the correlation with visual acuity improvement

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cataract
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014