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

NCT ID: NCT02526680

Last Updated: 2018-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Keywords

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OrCam Low-vision device End-stage glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Glaucoma Subjects

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

Group Type EXPERIMENTAL

OrCam

Intervention Type DEVICE

The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.

Interventions

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OrCam

The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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L. Jay Katz MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L. Jay Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Locations

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Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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14-396

Identifier Type: -

Identifier Source: org_study_id