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

Wills Eye

Status: Completed

Conditions: Glaucoma

Treatments: Device: OrCam

Study type: Interventional

Funder types: Other

Identifiers

NCT02526680

14-396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Glaucoma Subjects

Experimental group

Description:

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

Treatment:

Device: OrCam