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

The Impact of a Novel Artificial Vision Device (OrCam) on the Quality of Life of Patients With Advanced Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: OrCam

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glaucoma Subjects; 27 glaucoma subjects will be given the OrCam low vision aid device to use for 1 month.	Device: OrCam; The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Wills Eye
• Investigators: Principal Investigator: L. Jay Katz, MD, Wills Eye Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: OrCam; Low-vision device; End-stage glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 14-396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Manuscript accepted for publication August 2018.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes