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

Not Applicable

Completed

• Conditions: DR Population- With or Without Diabetic Macular Edema; AMD Population - Intermediate or Advanced AMD
• Interventions: Device: PAF (Positioning And Fixation device)

• Registration Number: NCT03270865
• Lead Sponsor: Notal Vision Ltd.

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.

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Study Start: 2017-09-30
• Primary Completion: 2018-02-01
• Study Completion: 2018-09-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usability and Ergonomic Evaluation of Self-Positioning System	PAF (Positioning And Fixation device)	-

Primary Outcome Measures

Name	Time	Method
spatial location of the pupil, during an eye examination	1 year	documentation of pupil location by a camera

Trial Locations

Locations (1)

Sorasky Medical Center; 🇮🇱 Tel Aviv, Israel