Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot (PAVE)
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training in the Use of Low Vision Devices
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring low vision, glaucoma
Eligibility 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.
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No training
Training in the Use of Low Vision Devices
Arm Description
Subjects will be fitted with low vision devices; no extra training will be provided.
Subjects will be fitted with low vision devices and will receive 6 training sessions with prescribed devices for up to 1 hour each time
Outcomes
Primary Outcome Measures
mobility
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00338208
Brief Title
Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
Acronym
PAVE
Official Title
Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
low vision, glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No training
Arm Type
No Intervention
Arm Description
Subjects will be fitted with low vision devices; no extra training will be provided.
Arm Title
Training in the Use of Low Vision Devices
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Training in the Use of Low Vision Devices
Primary Outcome Measure Information:
Title
mobility
Time Frame
At time of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Joos, MD, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
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Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot
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