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

This study has been terminated.
(PI left UAB; protocol administratively terminated by UAB IRB.)
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00585026
First received: December 21, 2007
Last updated: June 14, 2011
Last verified: December 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses on Symptoms and Performance on a Computer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • visual comfort index
  • productivity (correct words edited per hour)

Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00585026     History of Changes
Other Study ID Numbers: 1-Duam
Study First Received: December 21, 2007
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthenopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014