Refractive ErrorNCT00347620
Improving Vision and Quality of Life in the Nursing Home
A study testing spectacles and Cataract Surgery in people with Refractive Error and Cataract, run by University of Alabama at Birmingham at 17 sites in United States.
Trial summary
The primary purpose of this study is to evaluate whether interventions to improve vision in nursing home residents have an impact on residents' health-related quality of life. The interventions being evaluated are correction of refractive error (near-sightedness, far-sightedness, presbyopia) and cataract surgery. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error, Cataract
- What is being tested?
- spectacles and Cataract Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 400 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2000to Dec 2003
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 60 years of age or older
- expected to stay in facility foe at least 8 months
- stable medical condition
- moderately cognitively impaired or better
Who cannot join
- those not meeting inclusion criteria
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Integrated Health Services at Briarcliff
Alabaster, Alabama, 35007
Shelby Ridge Nursing Home
Alabaster, Alabama, 35007
Livingston Health Care Center
Bessemer, Alabama, 35020
Southgate Village
Bessemer, Alabama, 35020
Beverly Healthcare Meadowood
Bessemer, Alabama, 35023
Fair Haven Retirement Center
Birmingham, Alabama, 35210
Beverly Healthcare Center Forestdale
Birmingham, Alabama, 35214
Beverly Healthcare East
Birmingham, Alabama, 35215
South Haven
Birmingham, Alabama, 35226
Fairview Health & Rehabilitation Center
Birmingham, Alabama, 35228
Estes Nursing Facility Civic Center
Birmingham, Alabama, 35234
Estes Nursing Facility Northway
Birmingham, Alabama, 35234
Beverly Healthcare Riverchase
Birmingham, Alabama, 35244
Beverly Health Care Center West
Fairfield, Alabama, 35964
The Self Nursing Home, Inc
Hueytown, Alabama, 35023
Beverly Healthcare Pleasant Grove
Pleasant Grove, Alabama, 35127
Consult America Cottage Hills
Pleasant Grove, Alabama, 35127
About this study
The primary purpose of this study is to evaluate whether interventions to improve vision in nursing home residents have an impact on residents' health-related quality of life. The interventions being evaluated are correction of refractive error (near-sightedness, far-sightedness, presbyopia) and cataract surgery.
Read the detailed description
The purpose of this project is two-fold: 1.) to establish the psychometric properties of the Nursing Home Vision-Specific Health-Related Quality of Life (HRQOL) instrument, and; 2.) to evaluate the responsiveness of this instrument. Responsiveness will be assessed in two independent preliminary prospective intervention evaluations. The first responsiveness evaluation will involve a new spectacle intervention and the second will involve first eye cataract surgery. In addition, we will examine the association between the responsiveness of this instrument, and changes in visual functioning measures and other demographic variables.
- Conditions
- Refractive Error, Cataract
- Being tested
- spectacles, Cataract Surgery
- Medical subject headings
- Refractive Errors, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectaclesDevice
Cataract SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
vision-targeted health-related quality of life
Secondary outcomes (7)
depression
generic health-related quality of life
functional independence
participation in group activities
physical activities
falls
life space
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startAug 2000
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation, National Institute on Aging (NIA), National Eye Institute (NEI), Research to Prevent Blindness, EyeSight Foundation of Alabama, Pearle Vision Foundation
- Investigators
- Cynthia Owsley, PhD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347620
- Sponsor's protocol ID
- 2000-072
- Status last verified
- Mar 2010
- First submitted
- 30 Jun 2006
- Last updated
- 15 Mar 2010
- Results posted
- No
Publications
Owsley C, McGwin G Jr, Scilley K, Meek GC, Seker D, Dyer A. Effect of refractive error correction on health-related quality of life and depression in older nursing home residents. Arch Ophthalmol. 2007 Nov;125(11):1471-7. doi: 10.1001/archopht.125.11.1471.
PubMed 17998508
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vision and Quality of Life in the Nursing Home
- ClinicalTrials.gov ID
- NCT00347620
- Acronym / sponsor ID
- 2000-072
- Conditions
- Refractive Error, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Retirement Research Foundation, National Institute on Aging (NIA), National Eye Institute (NEI), Research to Prevent Blindness, EyeSight Foundation of Alabama, Pearle Vision Foundation
- Study start
- Aug 2000
- Study completion
- Dec 2003
- First posted
- 4 Jul 2006 (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.
The primary purpose of this study is to evaluate whether interventions to improve vision in nursing home residents have an impact on residents' health-related quality of life. The interventions being evaluated are correction of refractive error (near-sightedness, far-sightedness, presbyopia) and cataract surgery.
Detailed description
The purpose of this project is two-fold: 1.) to establish the psychometric properties of the Nursing Home Vision-Specific Health-Related Quality of Life (HRQOL) instrument, and; 2.) to evaluate the responsiveness of this instrument. Responsiveness will be assessed in two independent preliminary prospective intervention evaluations. The first responsiveness evaluation will involve a new spectacle intervention and the second will involve first eye cataract surgery. In addition, we will examine the association between the responsiveness of this instrument, and changes in visual functioning measures and other demographic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 60 years of age or older
- expected to stay in facility foe at least 8 months
- stable medical condition
- moderately cognitively impaired or better
Key exclusion criteria (1 listed)
- those not meeting inclusion criteria
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 |
|---|---|---|
| spectacles | Device | – |
| Cataract Surgery | Procedure or surgery | – |
Primary outcome
vision-targeted health-related quality of life
7 secondary outcomes
depression
generic health-related quality of life
functional independence
participation in group activities
physical activities
falls
life space
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 15 Mar 2010.
- Derived from this study: PubMed 17998508Owsley C, McGwin G Jr, Scilley K, Meek GC, Seker D, Dyer A. Effect of refractive error correction on health-related quality of life and depression in older nursing home residents. Arch Ophthalmol. 2007 Nov;125(11):1471-7. doi: 10.1001/archopht.125.11.1471.
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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.
Cynthia Owsley, PhD, MSPH principal investigator
University of Alabama at Birmingham
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectacles and Cataract Surgery in people with Refractive Error and Cataract, run by University of Alabama at Birmingham at 17 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 4 inclusion and 1 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 15 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
vision-targeted health-related quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00347620, which also lists 1 linked publication.
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 15 Mar 2010.