Clinical trial NCT02526680: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: OrCam
Low-vision device
End-stage glaucoma
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Impact of OrCam on Vision-related Quality of Life
timeFrame: 1 month
Secondary outcomes:
measure: Impact of OrCam on Reading Newspapers
timeFrame: 1 month
measure: Impact of OrCam on Grocery Shopping
timeFrame: 1 month
measure: Recommending OrCam to Others
timeFrame: 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: L. Jay Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: