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Trial record 35 of 1617 for:    glaucoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02526680
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : November 21, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Glaucoma
Intervention Device: OrCam
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description 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 Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
59.3
(22 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
8
  29.6%
Male
19
  70.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Impact of OrCam on Vision-related Quality of Life
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
20
  74.1%
2.Secondary Outcome
Title Impact of OrCam on Reading Newspapers
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description:
27 glaucoma subjects were given the OrCam low vision aid device to use for 1 month.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
15
  55.6%
3.Secondary Outcome
Title Impact of OrCam on Grocery Shopping
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description:
27 glaucoma subjects were given the OrCam low vision aid device to use for 1 month.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
5
  18.5%
4.Secondary Outcome
Title Recommending OrCam to Others
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description:
27 glaucoma subjects were given the OrCam low vision aid device to use for 1 month.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
23
  85.2%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glaucoma Subjects
Hide Arm/Group Description 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.
All-Cause Mortality
Glaucoma Subjects
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glaucoma Subjects
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glaucoma Subjects
Affected / at Risk (%)
Total   0/27 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. L. Jay Katz
Organization: Wills Eye Hospital Glaucoma Research Center
Phone: 215-928-3123
Responsible Party: L. Jay Katz MD, Wills Eye
ClinicalTrials.gov Identifier: NCT02526680     History of Changes
Other Study ID Numbers: 14-396
First Submitted: August 6, 2015
First Posted: August 18, 2015
Results First Submitted: December 21, 2017
Results First Posted: November 21, 2018
Last Update Posted: December 13, 2018