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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Joos, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00338208
First received: June 15, 2006
Last updated: August 19, 2015
Last verified: August 2015

June 15, 2006
August 19, 2015
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
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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: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Behavioral: Training in the Use of Low Vision Devices
  • 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
    Intervention: Behavioral: Training in the Use of Low Vision Devices
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
December 2011
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 information is only displayed when the study is recruiting subjects
United States
 
NCT00338208
Vanderbilt IRB #030642
No
Karen Joos, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Karen Joos, MD, PhD Vanderbilt University
Vanderbilt University
August 2015

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