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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00338208
First Posted: June 20, 2006
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karen Joos, Vanderbilt University
  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 Behavioral: Training in the Use of Low Vision Devices

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

Resource links provided by NLM:


Further study details as provided by Karen Joos, Vanderbilt University:

Primary Outcome Measures:
  • mobility [ Time Frame: At time of enrollment ]

Enrollment: 2
Study Start Date: October 2003
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No training
Subjects will be fitted with low vision devices; no extra training will be provided.
Experimental: Training in the Use of Low Vision Devices
Subjects will be fitted with low vision devices and will receive 6 training sessions with prescribed devices for up to 1 hour each time
Behavioral: Training in the Use of Low Vision Devices

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338208


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Karen Joos, MD, PhD Vanderbilt University
  More Information

Responsible Party: Karen Joos, Associate Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00338208     History of Changes
Other Study ID Numbers: Vanderbilt IRB #030642
First Submitted: June 15, 2006
First Posted: June 20, 2006
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Karen Joos, Vanderbilt University:
low vision
glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases


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