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Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients?

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OrCam
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma focused on measuring OrCam, Low-vision device, End-stage glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Glaucoma any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
  • Visual acuity of 20/400 to hand motion (HM) in better eye or visual field less than 10 degrees in better eye and having difficulty reading.
  • Age 18 years or older
  • Able to understand and speak English
  • Able to use an electronic recording device
  • Able to operate a computerized system

Exclusion Criteria:

  • Neurological or musculoskeletal problems that would influence performance on activities of daily living
  • Incisional eye surgery within past three months
  • Laser therapy within previous month
  • Any cause for visual impairment other than glaucoma
  • Photophobia
  • Any medical condition precluding subject from providing reliable, valid data

Sites / Locations

  • Wills Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glaucoma Subjects

Arm Description

27 glaucoma subjects will be given the OrCam low vision aid device to use for 1 month.

Outcomes

Primary Outcome Measures

Impact of OrCam on Vision-related Quality of Life
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) is a series of questions pertaining to vision or feelings about a vision condition in relation to functional status to assess their quality of life. Multiple choice responses from 12 subscales (general vision, near vision, distance vision, ocular pain, social functioning, mental health, roll difficulties, dependency, driving, color vision and peripheral vision) were recorded into a 0-100 score where 0 represents the lowest perceived vision difficulties and 100 the highest perceived difficulties. NEI-VFQ-25 was used to measure the number of participants who showed improvement in vision-related quality of life after using the OrCam device over a one month period.

Secondary Outcome Measures

Impact of OrCam on Reading Newspapers
Participants were asked 'Did OrCam increase your quality of life in reading newspapers?' after a one month trial period with the device. Number of subjects answering Yes is provided.
Impact of OrCam on Grocery Shopping
Participants were asked 'Did OrCam improve your quality of life while grocery shopping?' after a one month trial period with the device. Number of subjects answering Yes is provided.
Recommending OrCam to Others
Participants were asked 'How likely would you be to recommend OrCam to another visually impaired person?' after a one month trial period with the device. Number of subjects answering Very Likely or Likely is provided.

Full Information

First Posted
August 6, 2015
Last Updated
November 21, 2018
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT02526680
Brief Title
Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients?
Official Title
The Impact of a Novel Artificial Vision Device (OrCam) on the Quality of Life of Patients With Advanced Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the impact of OrCam over 1 month on health-related quality of life (HRQoL) in subjects with advanced glaucoma using the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25). To identify tasks for which subjects are using the OrCam device and patient satisfaction.
Detailed Description
Participants will document their daily impression about the use of OrCam, a small camera attached to their glasses over a 1-month period. They will attend 2 appointments at Wills Eye Hospital Glaucoma Research Center (baseline and final visit). Participant's will be trained to use the OrCam device at baseline visit and complete a best-corrected visual acuity assessment ETDRS (early treatment diabetic retinopathy study) and the NEI-VFQ-25 questionnaire. They will also read a short newspaper article. The NEI-VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question. Participants will read a short article. They will be asked to grade their reading difficulty between 1 (unable to read) to 10 (able to read without difficulty). Time to read article will be recorded. Reading task will be performed with best correction - with and without the assistance of the OrCam device. Subjects will utilize OrCam daily for one month. Each week, subjects will record thoughts about the device in a log book or by using audio tape recorder, according to patient's personal preference. Final assessment at 1 month will include best-corrected visual acuity (ETDRS), NEI-VFQ-25, and the newspaper-reading task with and without OrCam assistance. A satisfaction questionnaire will be completed in order to assess subjects' overall feelings regarding OrCam. Audio log books will be analyzed for specific factors and recorded by a research assistant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
OrCam, Low-vision device, End-stage glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma Subjects
Arm Type
Experimental
Arm Description
27 glaucoma subjects will be given the OrCam low vision aid device to use for 1 month.
Intervention Type
Device
Intervention Name(s)
OrCam
Intervention Description
The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.
Primary Outcome Measure Information:
Title
Impact of OrCam on Vision-related Quality of Life
Description
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) is a series of questions pertaining to vision or feelings about a vision condition in relation to functional status to assess their quality of life. Multiple choice responses from 12 subscales (general vision, near vision, distance vision, ocular pain, social functioning, mental health, roll difficulties, dependency, driving, color vision and peripheral vision) were recorded into a 0-100 score where 0 represents the lowest perceived vision difficulties and 100 the highest perceived difficulties. NEI-VFQ-25 was used to measure the number of participants who showed improvement in vision-related quality of life after using the OrCam device over a one month period.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Impact of OrCam on Reading Newspapers
Description
Participants were asked 'Did OrCam increase your quality of life in reading newspapers?' after a one month trial period with the device. Number of subjects answering Yes is provided.
Time Frame
1 month
Title
Impact of OrCam on Grocery Shopping
Description
Participants were asked 'Did OrCam improve your quality of life while grocery shopping?' after a one month trial period with the device. Number of subjects answering Yes is provided.
Time Frame
1 month
Title
Recommending OrCam to Others
Description
Participants were asked 'How likely would you be to recommend OrCam to another visually impaired person?' after a one month trial period with the device. Number of subjects answering Very Likely or Likely is provided.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Glaucoma any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect Visual acuity of 20/400 to hand motion (HM) in better eye or visual field less than 10 degrees in better eye and having difficulty reading. Age 18 years or older Able to understand and speak English Able to use an electronic recording device Able to operate a computerized system Exclusion Criteria: Neurological or musculoskeletal problems that would influence performance on activities of daily living Incisional eye surgery within past three months Laser therapy within previous month Any cause for visual impairment other than glaucoma Photophobia Any medical condition precluding subject from providing reliable, valid data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. Jay Katz, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Manuscript accepted for publication August 2018.

Learn more about this trial

Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients?

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