Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging

Study Overview
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Brief Summary
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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
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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.

Official Title
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Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging

Conditions
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AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema

Intervention / Treatment
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* Device: PAF (Positioning And Fixation device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usability and Ergonomic Evaluation of Self-Positioning System<br> | Device: PAF (Positioning And Fixation device)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spatial location of the pupil, during an eye examination | documentation of pupil location by a camera | 1 year |