Alzheimer's Disease Education and Referral Center

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 AgeMax AgeGenderHealthy 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 CityStateZip CodeStatusPrimary Contact

Geolocation is 41.5091257, -81.6089873

University Hospitals Case Medical Center
Cleveland
Ohio
44106
Recruiting
Jonathan Lass, MD
216-844-8588
jonathan.lass@uhhospitals.org

Geolocation is 41.4513221, -81.7021049

MetroHealth Medical Center
Cleveland
Ohio
44109
Recruiting
Thomas Steinemann, MD
216-778-2236
tsteinemann@metrohealth.org
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: 
NameRoleAffiliation
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: 
NamePhoneEmail
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