View Clinical Trial (Medical Research Study)
Therapeutic Effects of Cataract Removal in Alzheimer's Disease
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44109 |
| Conditions: |
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Cataracts - Alzheimer's Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- age 50 and older
- clinical diagnosis of possible/probable Alzheimer's disease, mild to moderate
severity (MMSE scores: 14-26 inclusive)
- bilateral visually significant cataracts
- best corrected visual acuity 20/50 or worse in better eye
- no ocular pathology
- subject is community-dwelling, or in assisted living facility
- 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
- subject resides in a long term nursing care facility
- subject does not desire cataract surgery
- 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 congestive heart failure and angina
- history of stroke in areas known to affect cognition
- history of renal failure
- life expectancy of less than 1 year
- Down's Syndrome
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| NCT ID: |
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NCT00921297 |
| Primary Contact: |
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Principal Investigator
Grover C. Gilmore, PhD.
Case Western Reserve University
Tatiana M. Riedel, BA
Phone: 216-368-6465
Email: tatiana.majer@case.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cleveland, Ohio 44109
United States
Thomas Steinemann, M.D.
Phone: 216-778-2236
Email: tsteinemann@metrohealth.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
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