Cataract Removal and Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Ocular |
| Therapuetic Areas: | Neurology, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 11/11/2017 |
| Start Date: | June 2009 |
| End Date: | March 30, 2017 |
Therapeutic Effects of Cataract Removal in Alzheimer's Disease
Two very common aging-related diseases in older adults are Alzheimer's disease (AD) and
cataracts. In elderly adults, these two diseases frequently occur in the same person.
Although a cure for AD is currently unavailable, cataracts can be effectively treated with
surgery in most people. The removal of cataracts has documented benefits for visual
performance and for reducing accidents and falls. However, it has been the experience of the
ophthalmologists, and others in the field, that patients, caregivers, and primary care
doctors are reluctant to proceed with cataract surgery once an individual is given the
diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's
quality of life, vision, and cognition. The investigators have designed this study to
determine whether or not this is true.
cataracts. In elderly adults, these two diseases frequently occur in the same person.
Although a cure for AD is currently unavailable, cataracts can be effectively treated with
surgery in most people. The removal of cataracts has documented benefits for visual
performance and for reducing accidents and falls. However, it has been the experience of the
ophthalmologists, and others in the field, that patients, caregivers, and primary care
doctors are reluctant to proceed with cataract surgery once an individual is given the
diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's
quality of life, vision, and cognition. The investigators have designed this study to
determine whether or not this is true.
In this project, we propose to test the following clinical hypothesis, while addressing the
primary and two secondary Specific Aims:
Hypothesis: Cataract removal produces measurable benefits in vision, perception, independent
function, and quality of life in patients with co-morbid Alzheimer's disease.
Primary Specific Aim: To determine the effects of cataract removal on visual acuity, spatial
contrast sensitivity, vision dependent functions, visual information processing, and quality
of life in patients with Alzheimer's disease.
Secondary Specific Aims.
1. To delineate the baseline characteristics of those patients who benefit most from the
surgical intervention.
2. To assess the thickness of the retinal nerve fiber layer (RNFL) with optical coherence
tomography (OCT) in large samples of AD patients classified with mild or moderate
dementia to determine if the thickness of the RNFL is associated with dementia severity,
visual performance measures, and other patient characteristics.
The study is designed as a Randomized Controlled Trial (RCT) with two cohorts of AD patients
in a longitudinal investigation. Each person will be evaluated periodically over a 6 month
period. All participants will be diagnosed with visually significant bilateral cataractous
lens. The cohorts will be established by randomly assigning patients to either the immediate
or the (optional) delayed surgery group. Patients will be stratified by AD severity (CDR mild
or moderate) and cataract severity prior to being randomized. Comparisons between and within
groups will test the change over time in vision, visual information processing, and quality
of life associated with or without the removal of cataracts. The RNFL thickness of each
person will be evaluated with optical coherence tomography (OCT). The thickness of the RNFL
will be compared across dementia severity levels. Each consented participant will have a
consenting study partner who may be referred to as a Research Partner, and who will often be
the participant's caregiver. The latter will help to assure protocol adherence by the AD
participants and will provide information about behavioral symptoms, activities of daily
living, and amount of resources used. The study will demonstrate the clinical efficacy of
cataract removal as a direct intervention to potentially improve the visual and cognitive
functions, and the quality of life in persons diagnosed with AD.
primary and two secondary Specific Aims:
Hypothesis: Cataract removal produces measurable benefits in vision, perception, independent
function, and quality of life in patients with co-morbid Alzheimer's disease.
Primary Specific Aim: To determine the effects of cataract removal on visual acuity, spatial
contrast sensitivity, vision dependent functions, visual information processing, and quality
of life in patients with Alzheimer's disease.
Secondary Specific Aims.
1. To delineate the baseline characteristics of those patients who benefit most from the
surgical intervention.
2. To assess the thickness of the retinal nerve fiber layer (RNFL) with optical coherence
tomography (OCT) in large samples of AD patients classified with mild or moderate
dementia to determine if the thickness of the RNFL is associated with dementia severity,
visual performance measures, and other patient characteristics.
The study is designed as a Randomized Controlled Trial (RCT) with two cohorts of AD patients
in a longitudinal investigation. Each person will be evaluated periodically over a 6 month
period. All participants will be diagnosed with visually significant bilateral cataractous
lens. The cohorts will be established by randomly assigning patients to either the immediate
or the (optional) delayed surgery group. Patients will be stratified by AD severity (CDR mild
or moderate) and cataract severity prior to being randomized. Comparisons between and within
groups will test the change over time in vision, visual information processing, and quality
of life associated with or without the removal of cataracts. The RNFL thickness of each
person will be evaluated with optical coherence tomography (OCT). The thickness of the RNFL
will be compared across dementia severity levels. Each consented participant will have a
consenting study partner who may be referred to as a Research Partner, and who will often be
the participant's caregiver. The latter will help to assure protocol adherence by the AD
participants and will provide information about behavioral symptoms, activities of daily
living, and amount of resources used. The study will demonstrate the clinical efficacy of
cataract removal as a direct intervention to potentially improve the visual and cognitive
functions, and the quality of life in persons diagnosed with AD.
Inclusion Criteria:
- age 50 and older
- clinical diagnosis of possible/probable Alzheimer's disease, or other type of
dementia, mild (CDR-1), moderate (CDR-2), or severe (CDR-3)
- at least 1 visually significant cataract
- no ocular pathology
- psychotropic drug must be with stable dosage for 30 days
Exclusion Criteria:
- history of cataract removal
- history of visually significant retinal, or optic nerve abnormalities
- informed consent cannot be obtained from either subject or their research partner
- subject shows evidence (in preoperative testing) of unstable cardiac or pulmonary
function
- history of uncontrolled diabetes or hypertension
- history of stroke in areas known to affect cognition
- life expectancy of less than 1 year
- Down's Syndrome
We found this trial at
2
sites
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