The Therapeutic Removal of Cataracts in Alzheimer’s Disease

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Information about the Research Study

What is this study about and why is it being conducted?

The removal of cataracts has well-known benefits for improving a person’s vision and for reducing accidents and falls. However, it has been the experience of our ophthalmologists and others in the field that patients, caregivers and primary care doctors are reluctant to proceed with cataract surgery for individuals diagnosed with dementia, Alzheimer’s disease (AD), and AD-related disorders. Some reasons for this include: (1) the patient is not complaining of vision problems, (2) the physician or caregiver is not sure whether the patient will be able to tolerate the surgery, and (3) the benefits of cataract surgery in this group of patients are not well-documented. Additionally, the dementia patient may not be aware that he or she may have a vision problem, and may think his or her dementia is the main reason they are having difficulties performing daily life activities.

Who is conducting the study?

Researchers at University Hospitals Case Medical Center, the MetroHealth Medical Center, and Case Western Reserve University are now enrolling patients in a research study sponsored by the National Institutes of Health.

What are the general study procedures?

Study Participants will first be screened to determine if they are eligible and then randomly selected into one of two groups: Group A (immediate surgery group), or Group B (delayed surgery group). Group A (immediate surgery group) will have their cataract surgery within 1 month of completing the screening visits. Group B (delayed surgery group) will be asked to delay their cataract surgery for 6 months. At the end of the study (after 6 to 8 months), all Study Participants will go through the same testing as they did in the beginning. This will allow the researchers to see whether there are any changes in the group that undergoes cataract surgery, or whether there are any differences between the “immediate” surgery group and the “delayed” surgery group.

How many study visits are there?

There are approximately 6 to 10 in-person study visits over the span of about 6 to 8 months time. Each of these visits is expected to last between 1 to 2 hours. You will also participate in 5 monthly follow-up telephone calls from our research staff. These calls are expected to take about 30 to 45 minutes each.

If I decide to participate, will I be able to continue under the care of my own eye doctor?

Yes. If you decide to participate in this study, we will inform your eye doctor about the procedures of this study. If you already have an ophthalmologist, he or she will be able to perform the cataract surgery and will conduct any pre- and post-operative clinical care visits. With your permission, we will ask your doctor for some information from your medical chart pertaining to your vision, your cataracts, and your cataract surgery.

However, there may be several visits that you will need to make with one of our study ophthalmologists. These will be “research visits” for which you will not be billed. During these visits, the study ophthalmologist will evaluate your cataracts, check your visual acuity, take pictures of your retinas, and perform an Optical Coherence Tomography (OCT) scan. The OCT scan is similar to an ultrasound of the eye, but uses light waves instead of sound waves. All of these research tests are completely non-invasive and will be free of charge to you.

Who is eligible to participate?

To be eligible:

* you must be at least 50 years or older,
* you must be experiencing memory loss or have a diagnosis of dementia or Alzheimer’s Disease,
* you must  have cataracts in both eyes,
* you must have a “study partner.”  A study partner is someone who knows you well enough to be able to answer some general questions about your health, your well-being and your ability to function in daily life,

What are the costs for participation?

All study-related visits, such as the neurological and neuropsychological exams, the screening and study-end eye exams, and any research-related tests will be provided to you free of charge. Additionally, each Participant and his or her Study Partner will be reimbursed $15 per study visit to cover any transportation and meal expenses. Cataract surgery is not considered a research-related procedure, but is the medical “standard of care” of care for anyone who has cataracts. Therefore, you, or your insurance company will be responsible for the costs related to your surgery and clinical follow-up.

If you are a patient of the Cleveland Clinic, or a health care system other than those listed above, you may contact the coordinator at the health care system most conveniently located to you.

Investigators

Contact Us

If you are a patient of the University Hospitals Case Medical Center system, your Study Coordinator will be:

Tatiana Riedel

Phone: 216-368-6465

E-mail: tjm6@case.edu

 

If you are a patient of the MetroHealth Medical System, your Study Coordinator will be:

Alicia O’Brien

Phone: 216-778-2461

E-mail: aobrien@metrohealth.org
If you are a patient of the Cleveland Clinic, or a health care system other than those listed above, you may contact the coordinator at the health care system most conveniently located to you.