Cataract Removal and Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital Case Medical Center
Sponsor:
Collaborators:
Case Western Reserve University
MetroHealth Medical Center
Information provided by (Responsible Party):
Grover C. Gilmore, PhD., Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00921297
First received: June 15, 2009
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cataracts
Alzheimer's Disease
Procedure: Immediate Cataract Surgery

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Visual acuity, spatial contrast sensitivity, visual perception and cognition [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921297

Contacts
Contact: Tatiana M. Riedel, BA 216-368-6465 tatiana.majer@case.edu

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jonathan Lass, M.D.    216-844-8588    jonathan.lass@uhhospitals.org   
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Thomas Steinemann, M.D.    216-778-2236    tsteinemann@metrohealth.org   
Sponsors and Collaborators
University Hospital Case Medical Center
Case Western Reserve University
MetroHealth Medical Center
Investigators
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 Hospital Case Medical Center
Study Director: Jonathan Lass, M.D. University Hospital Case Medical Center
Study Director: Alan Lerner, M.D. University Hospital Case Medical Center
Study Director: Thomas Steinemann, M.D. MetroHealth Medical Center
  More Information

No publications provided

Responsible Party: Grover C. Gilmore, PhD., Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00921297     History of Changes
Other Study ID Numbers: 04-09-21, 1R01AG030114
Study First Received: June 15, 2009
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Alzheimer's Disease
vision impairment
cataract
quality of life
retinal nerve fiber layer

Additional relevant MeSH terms:
Cataract
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014