Refractive ErrorsPhase 3NCT00317525
Effects of Different Add Powers on the Comfort and Productivity of Computer Users With Fixed or Free Head Movement
A Phase 3 study testing Spectacle Lenses in people with Refractive Errors and Asthenopia, run by American Optometric Association at 1 site in United States.
Trial summary
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Asthenopia
- What is being tested?
- Spectacle Lenses
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2006
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years of age or greater
- 20/40 visual acuity or better in each eye
- Use a computer at least 1 hour per work day
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. The investigators believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort.
Read the detailed description
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. We believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort. All subjects will be required to complete a vision screening at no charge to decide if they qualify for the study. This is a double-blind study, which means that neither the subject nor the doctors will know which pair of lenses you will be wearing during the parts of the study. Subjects will complete a total of 4 hours of testing. The total amount of testing will be divided into ten 15-minute periods. During each period, the investigator will place different lenses in a trial frame. The trial frame that the subject will wear during the experiment will have their prescription for near plus an unknown pair of lenses. During the testing, the subject will complete a task involving finding and deleting apostrophes from a manuscript on a standard computer. Either the investigator or co-investigator will explain how to do this simple task. Subjects will answer a short survey before and after these tasks to check on symptoms resulting from using the computer. The following periodic measurements will be made during the study: productivity and accuracy to search for apostrophes (') in a document on one of the states of the U.S. These tasks will require a total of 4 hours testing with a total of ten pairs of trial lenses during a single visit.
- Conditions
- Refractive Errors, Asthenopia
- Being tested
- Spectacle Lenses
- Keywords
- Refractive error, Asthenopia
- Medical subject headings
- Refractive Errors, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle LensesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual comfort
Productivity (correct words per hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startMay 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- American Optometric Association
- Sponsor type
- University, hospital or other
- Investigators
- Kent M Daum, O.D., Ph.D., Principal investigator, School of Optometry, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317525
- Sponsor's protocol ID
- X050314015
- Status last verified
- May 2005
- First submitted
- 21 Apr 2006
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Add Powers on the Comfort and Productivity of Computer Users With Fixed or Free Head Movement
- ClinicalTrials.gov ID
- NCT00317525
- Acronym / sponsor ID
- X050314015
- Conditions
- Refractive Errors, Asthenopia
- Keywords
- Refractive error, Asthenopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- American Optometric AssociationUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Jun 2006
- First posted
- 25 Apr 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 aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. The investigators believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort.
Detailed description
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. We believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort. All subjects will be required to complete a vision screening at no charge to decide if they qualify for the study. This is a double-blind study, which means that neither the subject nor the doctors will know which pair of lenses you will be wearing during the parts of the study. Subjects will complete a total of 4 hours of testing. The total amount of testing will be divided into ten 15-minute periods. During each period, the investigator will place different lenses in a trial frame. The trial frame that the subject will wear during the experiment will have their prescription for near plus an unknown pair of lenses. During the testing, the subject will complete a task involving finding and deleting apostrophes from a manuscript on a standard computer. Either the investigator or co-investigator will explain how to do this simple task. Subjects will answer a short survey before and after these tasks to check on symptoms resulting from using the computer. The following periodic measurements will be made during the study: productivity and accuracy to search for apostrophes (') in a document on one of the states of the U.S. These tasks will require a total of 4 hours testing with a total of ten pairs of trial lenses during a single visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age or greater
- 20/40 visual acuity or better in each eye
- Use a computer at least 1 hour per work day
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Spectacle Lenses | Device | – |
Primary outcome
Visual comfort
Productivity (correct words per hour)
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 11 Sep 2006.
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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.
Kent M Daum, O.D., Ph.D. principal investigator
School of Optometry, University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spectacle Lenses in people with Refractive Errors and Asthenopia, run by American Optometric Association at 1 site 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 3 inclusion and 0 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 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 comfort. The study lists 2 primary outcomes in all. 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 11 Sep 2006.