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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
History of Changes
  Purpose

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


Condition Intervention
Glaucoma
 Device: low vision device
Device: Fitting of Low Vision Device
Device: Education of Low Vision Devices
Device: Low Vision Aides

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • mobility [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2003
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

Detailed Description:

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 .

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338208

Contacts
Contact: Karen Joos, MD, PhD 615-936-3465 sandy.owings@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sandy Owings, COA     615-936-3465     sandy.owings@vanderbilt.edu    
Principal Investigator: Karen Joos, MD,PhD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Karen Joos, MD, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Karen Joos, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00338208     History of Changes
Other Study ID Numbers: Vanderbilt IRB #030642
Study First Received: June 15, 2006
Last Updated: July 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
low vision
glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013