Cataract Removal and Alzheimer's Disease
Cataract Removal and Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
The removal of cataracts can improve vision and reduce accidents and falls. However, some individuals, caregivers, and primary care doctors are reluctant to proceed with cataract surgery once an individual is diagnosed with Alzheimer's disease because they think that cataract surgery will not improve the person's quality of life, vision, and cognition. The investigators have designed this study to determine whether or not this belief is true.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Clinical diagnosis of possible/probable mild to moderate Alzheimer's disease (MMSE scores: 14-26 inclusive)
- Bilateral visually significant cataracts
- Best corrected visual acuity of 20/50 or worse in better eye
- Community dwelling (including assisted living)
- If taking psychotropic drug, must be with stable dosage for 30 days
Exclusion Criteria:
- History of cataract removal; ocular pathology; or visually significant retinal or optic nerve abnormalities
- Resides in a long-term nursing care facility
- No desire for cataract surgery
- Evidence of unstable cardiac or pulmonary function
- History of uncontrolled diabetes, hypertension, congestive heart failure, angina, stroke in areas known to affect cognition, or renal failure
- Life expectancy of less than 1 year
- Down's syndrome
Detailed Description:
The investigators hypothesize that cataract removal will produce measurable benefits in vision, perception, independent function, and quality of life in people with Alzheimer's disease. To test this hypothesis, they will conduct a randomized controlled trial in people with Alzheimer's and cataracts. Participants will be randomly assigned to either the immediate cataract removal group or the (optional) delayed surgery group. Patients will be stratified by Alzheimer's severity (mild or moderate) and cataract severity prior to being randomized. Comparisons between and within groups will test changes over 6 months in vision, visual information processing, and quality of life associated with or without the removal of cataracts.
Study partners (caregivers) will help assure protocol adherence by participants and will provide information about behavioral symptoms, activities of daily living, and resources used.
Investigators will delineate the baseline characteristics of patients who benefit most from cataract surgery. They will also assess the thickness of the retinal nerve fiber layer to determine if its thickness is associated with dementia severity, visual performance measures, and other patient characteristics.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 41.5091257, -81.6089873 | University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | Recruiting | |
Geolocation is 41.4513221, -81.7021049 | MetroHealth Medical Center | Cleveland | Ohio | 44109 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University Hospitals Case Medical Center |
Collaborator Sponsor:
| Agency |
|---|
Case Western Reserve University |
MetroHealth Medical Center |
National Institutes of Health (NIH) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Grover C. Gilmore, PhD | Principal Investigator | Case Western Reserve University |
Sara Debanne, PhD | Study Director | Case Western Reserve University |
Julie Belkin, MD | Study Director | University Hospitals Case Medical Center |
Jonathan Lass, MD | Study Director | University Hospitals Case Medical Center |
Alan Lerner, MD. | Study Director | University Hospitals Case Medical Center |
Thomas Steinemann, MD | Study Director | MetroHealth Medical Center |
Study Contact:
| Name | Phone | |
|---|---|---|
Tatiana M. Riedel | 216-368-6465 |
Locations
ClinicalTrials.gov ID
NCT00921297 (follow link to view full record on ct.gov in new window)
Official Title:
Therapeutic Effects of Cataract Removal in Alzheimer's Disease
Study Start Date:
June 2009
Study End Date:
June 2014
Disease Stage:
Early
Middle
Enrollment:
210
