Back to resultsUsability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
Primary Purpose
AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PAF (Positioning And Fixation device)
Sponsored by
About this trial
This is an interventional other trial for AMD Population - Intermediate or Advanced AMD
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 65
- Able to understand and sign the informed consent form
- Ability to communicate verbally
- AMD (interim and advanced) or diabetic retinopathy (with and without DME)
Exclusion Criteria:
- Visual acuity >=20/200 in the better eye
Sites / Locations
- Sorasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Usability and Ergonomic Evaluation of Self-Positioning System
Arm Description
Outcomes
Primary Outcome Measures
spatial location of the pupil, during an eye examination
documentation of pupil location by a camera
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03270865
Brief Title
Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
Official Title
Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Notal Vision Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment
Detailed Description
One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usability and Ergonomic Evaluation of Self-Positioning System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PAF (Positioning And Fixation device)
Intervention Description
Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation.
The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded.
Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes.
Primary Outcome Measure Information:
Title
spatial location of the pupil, during an eye examination
Description
documentation of pupil location by a camera
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 65
Able to understand and sign the informed consent form
Ability to communicate verbally
AMD (interim and advanced) or diabetic retinopathy (with and without DME)
Exclusion Criteria:
Visual acuity >=20/200 in the better eye
Facility Information:
Facility Name
Sorasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
We'll reach out to this number within 24 hrs