Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00338208
First received: June 15, 2006
Last updated: July 12, 2010
Last verified: July 2010

June 15, 2006
July 12, 2010
October 2003
December 2010   (final data collection date for primary outcome measure)
mobility [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
  • mobility
  • reading ability
Complete list of historical versions of study NCT00338208 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

We wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. We hypothesize that the devices will improve efficiency. Prescribed devices will include a stand magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance vision. The success of being able to use optical devices is dependent upon training. Optical devices are currently accepted and used for patients with visual conditions that decrease their central vision. The bioptic telescope is a pair of glasses with a small telescope mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but have a black device (telescope) protruding from the top of one lens for better identifying distance objects. The spectacle magnifier is mounted in a pair of glasses also for near vision

You will be asked a series of oral questions regarding your health status and vision level of functioning (Expectations of Visual Functioning Form, NEI-VFQ, Linear Rating Scale, and Geriatric Depression Scale) in the Vanderbilt Eye Clinic. You will undergo a mobility pre-test to assess your ability to find objects in the distance as well as read . You will undergo a low vision examination in the eye clinic. You will receive the optical devices and then receive brief instructions on the use of the devices . You will then undergo a pre-training evaluation. You will receive approximately 6 training sessions with your prescribed devices for up to 1 hour each time. You will return to the Vanderbilt Eye Clinic for the post-training distance and near vision assessments with the devices . You will be asked the series of oral questions again regarding your health status and vision level of functioning .

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • Device: low vision device
    Subjects examined to determine the low vision device that best meets their visual needs
    Other Names:
    • Low vision devices
    • Glasses
    • Telescopes
    • Monitor
    • Magnifying glasses
  • Device: Fitting of Low Vision Device
    Low vision device to be fitted to assist with low vision
    Other Name: Training for usage of low vision device
  • Device: Education of Low Vision Devices
    Education of usage of low vision device
    Other Names:
    • Glasses
    • Magnifying lenses
    • Monitors
    • Telescopes
  • Device: Low Vision Aides
    Low vision aides
    Other Name: Glasses,magnigying lenses, telescopes, monitors
  • No Intervention: Control
    Participants will be enrolled due to their low vision and low vision devices will be attempted to assist them visually
  • Lifestyle Counseling
    The subjects will be fitted with low vision devices to attempt to improve visual quality
    Interventions:
    • Device: low vision device
    • Device: Fitting of Low Vision Device
    • Device: Education of Low Vision Devices
    • Device: Low Vision Aides
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2012
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Glaucoma patients with vision less than 20/40

Exclusion criteria:

- Subjects must not have any significant physical mobility limitations and be willing to participate in the testing and training sessions.

Both
21 Years and older
Yes
Contact: Karen Joos, MD, PhD 615-936-3465 sandy.owings@vanderbilt.edu
United States
 
NCT00338208
Vanderbilt IRB #030642
No
Karen Joos, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Karen Joos, MD, PhD Vanderbilt University
Vanderbilt University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP