Trial Outcomes & Findings for Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients? (NCT NCT02526680)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

1 month

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Glaucoma Subjects 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glaucoma Subjects n=27 Participants 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month.
Age, Continuous	59.3 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glaucoma Subjects n=27 Participants 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month after using the device to measure improvement in perceived vision-related quality of life.
Impact of OrCam on Vision-related Quality of Life	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glaucoma Subjects n=27 Participants 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month after using the device to measure improvement in perceived vision-related quality of life.
Impact of OrCam on Reading Newspapers	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glaucoma Subjects n=27 Participants 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month after using the device to measure improvement in perceived vision-related quality of life.
Impact of OrCam on Grocery Shopping	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glaucoma Subjects n=27 Participants 27 glaucoma subjects were given the OrCam low vision aid device to use for one month. National Eye Institute Visual Function Questionnaire - 25 (NEI-VFQ-25) was administered at baseline and 1 month after using the device to measure improvement in perceived vision-related quality of life.
Recommending OrCam to Others	23 Participants

Adverse Events

Glaucoma Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. L. Jay Katz

Wills Eye Hospital Glaucoma Research Center

Phone: 215-928-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place