CataractsNCT00921297
Cataract Removal and Alzheimer's Disease
A study testing Immediate Cataract Surgery in people with Cataracts and Alzheimer's Disease, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataracts, Alzheimer's Disease
- What is being tested?
- Immediate Cataract Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Therapeutic Effects of Cataract Removal in Alzheimer's Disease
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.
Read the 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.
- 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.
- Conditions
- Cataracts, Alzheimer's Disease
- Being tested
- Immediate Cataract Surgery
- Keywords
- Alzheimer's Disease, vision impairment, cataract, quality of life, retinal nerve fiber layer
- Medical subject headings
- Cataract, Alzheimer Disease, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Cataract SurgeryProcedure or surgery
Cataract surgery, as part of standard of care, will be performed on 1/2 of the group under investigation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Cataract Surgery | Active comparator | 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. Receives: Procedure: Immediate Cataract Surgery |
| Delayed Cataract Surgery | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity, spatial contrast sensitivity, visual perception and cognition
Measured: Baseline and Month 6
Secondary outcomes (3)
Independent function
Measured: Baseline and Month 6
Quality of Life
Measured: Baseline and Month 6
Retinal Nerve Fiber Layer
Measured: Baseline, Months 2,4, & 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, MetroHealth Medical Center, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Grover C. Gilmore, PhD., Case Western Reserve University
- Investigators
- Grover C. Gilmore, PhD., Principal investigator, Case Western Reserve UniversitySara Debanne, PhD., Study director, Case Western Reserve UniversityJulie Belkin, M.D., Study director, University Hospitals Cleveland Medical CenterJonathan Lass, M.D., Study director, University Hospitals Cleveland Medical CenterAlan Lerner, M.D., Study director, University Hospitals Cleveland Medical CenterThomas Steinemann, M.D., Study director, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921297
- Sponsor's protocol ID
- 04-09-21
- Other IDs
- 1R01AG030114
- Status last verified
- Nov 2017
- First submitted
- 15 Jun 2009
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Cataract Removal in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00921297
- Acronym / sponsor ID
- 04-09-21
- Conditions
- Cataracts, Alzheimer's Disease
- Keywords
- Alzheimer's Disease, vision impairment, cataract, quality of life, retinal nerve fiber layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, MetroHealth Medical Center, National Institute on Aging (NIA)
- Study start
- Jun 2009
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Cataract Surgery | Active comparator | Procedure: Immediate Cataract SurgerySubjects 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. |
| Delayed Cataract Surgery | No intervention | –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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Cataract SurgeryCataract surgery, as part of standard of care, will be performed on 1/2 of the group under investigation. | Procedure or surgery | Immediate Cataract Surgery |
Primary outcome
Visual acuity, spatial contrast sensitivity, visual perception and cognition
Time frame: Baseline and Month 6
3 secondary outcomes
Independent function
Time frame: Baseline and Month 6
Quality of Life
Time frame: Baseline and Month 6
Retinal Nerve Fiber Layer
Time frame: Baseline, Months 2,4, & 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grover C. Gilmore, PhD. principal investigator
Case Western Reserve University
Sara Debanne, PhD. study director
Case Western Reserve University
Julie Belkin, M.D. study director
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Cataract Surgery in people with Cataracts and Alzheimer's Disease, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity, spatial contrast sensitivity, visual perception and cognition (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.