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

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ClinicalTrials.gov Identifier: NCT02526680
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : November 21, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Study Description
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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.


Condition or disease Intervention/treatment Phase
Glaucoma Device: OrCam Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of a Novel Artificial Vision Device (OrCam) on the Quality of Life of Patients With Advanced Glaucoma
Study Start Date : May 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Impact of OrCam on Vision-related Quality of Life [ Time Frame: 1 month ]
    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 :
  1. Impact of OrCam on Reading Newspapers [ Time Frame: 1 month ]
    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.

  2. Impact of OrCam on Grocery Shopping [ Time Frame: 1 month ]
    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.

  3. Recommending OrCam to Others [ Time Frame: 1 month ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526680


Locations
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United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
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Principal Investigator: L. Jay Katz, MD Wills Eye Hospital
More Information
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Responsible Party: L. Jay Katz MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT02526680    
Other Study ID Numbers: 14-396
First Posted: August 18, 2015    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Manuscript accepted for publication August 2018.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by L. Jay Katz MD, Wills Eye:
OrCam
Low-vision device
End-stage glaucoma
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases