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Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses

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ClinicalTrials.gov Identifier: NCT00585026
Recruitment Status : Terminated (PI left UAB; protocol administratively terminated by UAB IRB.)
First Posted : January 2, 2008
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
University of Alabama at Birmingham

Brief Summary:
This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO Computer Lenses for persons using a computer. We hypothesize that lenses specially designed for computer use may allow more comfortable and productive work on a computer.

Condition or disease Intervention/treatment Phase
Refractive Error Presbyopia Asthenopia Eyeglasses Device: D-28 bifocal lenses and frame Device: Progressive addition computer lenses and frame Phase 3

Detailed Description:

This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO Computer Lenses for persons using a computer. These are different types of eyeglass lenses and are commonly used when performing computer work. D-shaped bifocal lenses are designed for general purpose use and PRIO Computer Lenses are progressive addition lenses designed for using a computer and are not useful for driving or other tasks requiring clear distance vision. The study will examine how much work a subject completes during a 2-hr visit to the laboratory (productivity) and how a subject feels when working (symptoms). The UAB Department of Optometry sponsors this research study. Interested individuals must be at least 40 years of age and have relatively good vision in each eye when wearing glasses and to do at least 4-hrs of computer work per workday. There are no other restrictions to enter the study.

Participating subjects will be provided one of two different types of lenses and a choice of eyeglass frames. All subjects will be required to use the pair of glasses provided for all computer work for a period of 4 months. During the fourth and eighth weeks of this period, subjects will be required to complete three short surveys over the phone (10 questions) a day for five days (morning, noon and afternoon) on how the glasses affect their work on a computer and how they feel. These surveys should take about 5 minutes or less to complete. During the fifth or sixth week, subjects would be required to visit the laboratory at the School of Optometry to do 2-hours of editing tasks on a computer and complete the same short survey before beginning and after finishing. Participants would be called once a week to confirm that they are wearing the glasses. These calls would last about 2-3 minutes or less.

Upon qualifying for the study, subjects will be randomly (like the flip of a coin) assigned by a computer to receive either the bifocal lenses or the variable focus computer glasses. This will be a single-blind study, which means that neither your doctors completing the survey and the on-site visit will not be informed which type of glasses the subject is using.

The following periodic measurements will be made during the study: visual and upper extremity comfort (surveys) and productivity (editing task). Subjects will be asked to return to the clinic for 1 2-hr visit. At each visit subjects will be asked if they have experienced any undesirable reactions and how they are tolerating the glasses.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses on Symptoms and Performance on a Computer
Study Start Date : October 2006
Actual Study Completion Date : June 2007



Primary Outcome Measures :
  1. visual comfort index
  2. productivity (correct words edited per hour)


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 40 yrs of age or greater
  • 20/40 or better corrected visual acuity in each eye
  • 4 hrs or more of computer use per workday

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585026


Locations
United States, Alabama
School of Optometry
Birmingham, Alabama, United States, 35294-0010
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Kent M. Daum, O.D., Ph.D. School of Optometry, University of Alabama at Birmingham

ClinicalTrials.gov Identifier: NCT00585026     History of Changes
Other Study ID Numbers: 1-Duam
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: December 2009

Keywords provided by University of Alabama at Birmingham:
Refractive error
Asthenopia
Presbyopia
Eyeglasses
Productivity
Visual comfort
Ergonomics

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Asthenopia
Eye Diseases