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Adult PAVE - Glaucoma Pilot
This study is currently recruiting participants.
Verified by Vanderbilt University, July 2007
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00338208
  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 efficeincy. 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

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Eye Wear Glaucoma Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Adult PAVE - Glaucoma Pilot

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • mobility
  • reading ability

Estimated Enrollment: 10
Study Start Date: October 2003
Estimated Study Completion Date: December 2008
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

Study ID Numbers: Vanderbilt IRB #030642
Study First Received: June 15, 2006
Last Updated: July 16, 2007
ClinicalTrials.gov Identifier: NCT00338208  
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
low vision
glaucoma

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Vision, Low
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009