Cataract Removal and Alzheimer's Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Therapeutic Effects of Cataract Removal in Alzheimer's Disease|
- Visual acuity, spatial contrast sensitivity, visual perception and cognition [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
- Independent function [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
- Retinal Nerve Fiber Layer [ Time Frame: Baseline, Months 2,4, & 6 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
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.
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.
- To delineate the baseline characteristics of those patients who benefit most from the surgical intervention.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921297
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|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|