Refractive ErrorPhase 3NCT00318045
Effects of Optical Blur on Performance and Comfort of Computer Users
A Phase 3 study testing Eyeglass lenses in people with Refractive Error, run by Vision Council of America 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 workers using computers and their productivity and comfort in the workplace. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- Eyeglass lenses
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 yrs of age or more
- Use a computer for 1 hr per day or more
- 20/40 or better visual acuity in each eye
Who cannot join
- None
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 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.
Read the detailed description
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of 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 you qualify for the study. Subjects will select a frame to be worn during the period of the study. Subjects will wear either your best correction or your present prescription in the frame for a period of 1-month. This will be a double-blind study, which means that neither the subject nor your doctors will know which pair of glasses the subjects will be wearing during the parts of the study. Subjects will complete 4 hours of testing during the first period (4 weeks) then the lenses will be switched for the second period (4 weeks). During the testing, subjects will complete two tasks on a standard computer. Either the investigator or co-investigator will explain to you how to do these simple tasks. One of these tasks will involve looking at printed material and entering correct information into the computer. The other task involves finding and deleting apostrophes from a manuscript on the computer. All subjects will answer a short survey before and after these tasks to check on symptoms resulting from using the computer. Before and after each period, the subjects also will answer another survey to measure their visual functioning using these glasses.
The following periodic measurements will be made during the study: productivity and accuracy to enter a list of state populations, and a search for apostrophes (') in a document on one of the states of the U.S. These tasks will require 4 hours testing with each of the two pairs of trial glasses for two periods (each period lasts for one month). Subjects will be asked to return to the clinic for 4 hrs during the first 4-week period and for 4 more hrs during the second 4-week period. At each visit subjects will be asked if they have experienced any undesirable reactions and will complete a short survey.
Subjects will also be required to complete a short 9-question survey to determine their visual comfort before and after 1-hour of work on their own computer at your home or job during each 1-month period of the study. These short phone surveys will take less than 5-minutes to complete and will be arranged at the subject's convenience before and after the subjects are going to be working on your computer for at least 1-hr. This survey will be repeated on five occasions. Finally, 3-months after the experimental portion of the study is completed, all subjects will be required to also answer the same short 9-question survey as you work on your computer. This will also be a phone survey and will be completed on three occasions before and after 1-hr of work on their own computer at home or job.
- Conditions
- Refractive Error
- Being tested
- Eyeglass 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.
Eyeglass lensesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual comfort
Productivity (correct output 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 startOct 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Vision Council of America
- 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
- NCT00318045
- Sponsor's protocol ID
- X050208014
- Status last verified
- Apr 2006
- First submitted
- 21 Apr 2006
- Last updated
- 25 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Optical Blur on Performance and Comfort of Computer Users
- ClinicalTrials.gov ID
- NCT00318045
- Acronym / sponsor ID
- X050208014
- Conditions
- Refractive Error
- Keywords
- Refractive error, Asthenopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants
- Lead sponsor
- Vision Council of AmericaUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Apr 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 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.
Detailed description
The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of 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 you qualify for the study. Subjects will select a frame to be worn during the period of the study. Subjects will wear either your best correction or your present prescription in the frame for a period of 1-month. This will be a double-blind study, which means that neither the subject nor your doctors will know which pair of glasses the subjects will be wearing during the parts of the study. Subjects will complete 4 hours of testing during the first period (4 weeks) then the lenses will be switched for the second period (4 weeks). During the testing, subjects will complete two tasks on a standard computer. Either the investigator or co-investigator will explain to you how to do these simple tasks. One of these tasks will involve looking at printed material and entering correct information into the computer. The other task involves finding and deleting apostrophes from a manuscript on the computer. All subjects will answer a short survey before and after these tasks to check on symptoms resulting from using the computer. Before and after each period, the subjects also will answer another survey to measure their visual functioning using these glasses.
The following periodic measurements will be made during the study: productivity and accuracy to enter a list of state populations, and a search for apostrophes (') in a document on one of the states of the U.S. These tasks will require 4 hours testing with each of the two pairs of trial glasses for two periods (each period lasts for one month). Subjects will be asked to return to the clinic for 4 hrs during the first 4-week period and for 4 more hrs during the second 4-week period. At each visit subjects will be asked if they have experienced any undesirable reactions and will complete a short survey.
Subjects will also be required to complete a short 9-question survey to determine their visual comfort before and after 1-hour of work on their own computer at your home or job during each 1-month period of the study. These short phone surveys will take less than 5-minutes to complete and will be arranged at the subject's convenience before and after the subjects are going to be working on your computer for at least 1-hr. This survey will be repeated on five occasions. Finally, 3-months after the experimental portion of the study is completed, all subjects will be required to also answer the same short 9-question survey as you work on your computer. This will also be a phone survey and will be completed on three occasions before and after 1-hr of work on their own computer at home or job.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 yrs of age or more
- Use a computer for 1 hr per day or more
- 20/40 or better visual acuity in each eye
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Eyeglass lenses | Device | – |
Primary outcome
Visual comfort
Productivity (correct output per hour)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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 Eyeglass lenses in people with Refractive Error, run by Vision Council of America 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 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: status not confirmed, as of the sponsor's last update on 25 Apr 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?
Results are not available in the source record.
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 25 Apr 2006.