NCT02526680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

November 21, 2018

Completed
Last Updated

December 13, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

August 6, 2015

Results QC Date

December 21, 2017

Last Update Submit

November 21, 2018

Conditions

Glaucoma

Keywords

OrCamLow-vision deviceEnd-stage glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Impact of OrCam on Reading Newspapers

    1 month

  • Impact of OrCam on Grocery Shopping

    1 month

  • Recommending OrCam to Others

    1 month

Study Arms (1)

Glaucoma Subjects

EXPERIMENTAL

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

Device: OrCam

Interventions

OrCamDEVICE

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

Glaucoma Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Limitations and Caveats

OrCam device requires further improvement. Cost of OrCam poses limitation on access to many individuals and is not covered by most health insurance plans in the United States for visually impaired patients.

Results Point of Contact

Title
Dr. L. Jay Katz
Organization
Wills Eye Hospital Glaucoma Research Center
ljkatz@willseye.org
215-928-3123

Study Officials

  • L. Jay Katz, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 18, 2015

Study Start

May 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

December 13, 2018

Results First Posted

November 21, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Manuscript accepted for publication August 2018.

Locations

US(1)