Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338208
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2006-06-15
Brief Title:
Adult Providing Access to the Visual Environment PAVE - Glaucoma Pilot
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Adult Providing Access to the Visual Environment PAVE - Glaucoma Pilot
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAVE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None