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

NCT ID: NCT00338208

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2011-12-31

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 .

Conditions

Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No training

Subjects will be fitted with low vision devices; no extra training will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Training in the Use of Low Vision Devices

Intervention Type: BEHAVIORAL

Interventions

Training in the Use of Low Vision Devices

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Karen Joos

Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Joos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Vanderbilt IRB #030642

Identifier Type: -

Identifier Source: org_study_id