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

Primary Purpose

Refractive Error, Presbyopia, Asthenopia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
D-28 bifocal lenses and frame
Progressive addition computer lenses and frame
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring Refractive error, Asthenopia, Presbyopia, Eyeglasses, Productivity, Visual comfort, Ergonomics

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Optometry

Outcomes

Primary Outcome Measures

visual comfort index
productivity (correct words edited per hour)

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
June 14, 2011
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00585026
Brief Title
Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses
Official Title
Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses on Symptoms and Performance on a Computer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
PI left UAB; protocol administratively terminated by UAB IRB.
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Presbyopia, Asthenopia, Eyeglasses
Keywords
Refractive error, Asthenopia, Presbyopia, Eyeglasses, Productivity, Visual comfort, Ergonomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
D-28 bifocal lenses and frame
Intervention Type
Device
Intervention Name(s)
Progressive addition computer lenses and frame
Primary Outcome Measure Information:
Title
visual comfort index
Title
productivity (correct words edited per hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent M. Daum, O.D., Ph.D.
Organizational Affiliation
School of Optometry, University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0010
Country
United States

12. IPD Sharing Statement

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

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