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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00318045
Other study ID # X050208014
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received April 21, 2006
Last updated April 21, 2006
Start date October 2005
Est. completion date April 2006

Study information

Verified date April 2006
Source Vision Council of America
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. We believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 35
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Eyeglass lenses


Locations

Country Name City State
United States School of Optometry Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
Vision Council of America

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual comfort
Primary Productivity (correct output per hour)
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