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Cataract Removal and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00921297
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : November 9, 2017
Case Western Reserve University
MetroHealth Medical Center
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Grover C. Gilmore, PhD., Case Western Reserve University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataracts Alzheimer's Disease Procedure: Immediate Cataract Surgery Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Therapeutic Effects of Cataract Removal in Alzheimer's Disease
Study Start Date : June 2009
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Immediate Cataract Surgery
Subjects randomly selected into the Immediate Surgery group will have their cataract surgery scheduled one month from the time their initial study visits are completed. The subjects will be followed monthly for a period of 6 months for surgical and non-surgical adverse events. At the 6-month point, subjects will receive a final comprehensive eye exam and neuropsychological testing. The research partners will complete final activities of daily living and resource utilization questionnaires.
Procedure: Immediate Cataract Surgery
Cataract surgery, as part of standard of care, will be performed on 1/2 of the group under investigation.

No Intervention: Delayed Cataract Surgery
Subjects selected into the Delayed Surgery group will be asked to delay their surgery for 6 months after their initial study visits. At 6 months, this group will also undergo the same testing as the Surgery Group.

Primary Outcome Measures :
  1. Visual acuity, spatial contrast sensitivity, visual perception and cognition [ Time Frame: Baseline and Month 6 ]

Secondary Outcome Measures :
  1. Independent function [ Time Frame: Baseline and Month 6 ]
  2. Quality of Life [ Time Frame: Baseline and Month 6 ]
  3. Retinal Nerve Fiber Layer [ Time Frame: Baseline, Months 2,4, & 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT00921297

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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Case Western Reserve University
MetroHealth Medical Center
National Institute on Aging (NIA)
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Principal Investigator: Grover C. Gilmore, PhD. Case Western Reserve University
Study Director: Sara Debanne, PhD. Case Western Reserve University
Study Director: Julie Belkin, M.D. University Hospitals Cleveland Medical Center
Study Director: Jonathan Lass, M.D. University Hospitals Cleveland Medical Center
Study Director: Alan Lerner, M.D. University Hospitals Cleveland Medical Center
Study Director: Thomas Steinemann, M.D. MetroHealth Medical Center
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Responsible Party: Grover C. Gilmore, PhD., Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00921297    
Other Study ID Numbers: 04-09-21
1R01AG030114 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Keywords provided by Grover C. Gilmore, PhD., Case Western Reserve University:
Alzheimer's Disease
vision impairment
quality of life
retinal nerve fiber layer
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Lens Diseases
Eye Diseases