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

NCT ID: NCT03270865

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usability and Ergonomic Evaluation of Self-Positioning System

Group Type: EXPERIMENTAL

PAF (Positioning And Fixation device)

Intervention Type: DEVICE

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.

Interventions

PAF (Positioning And Fixation device)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sorasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

Notal U-001 V. 1.0

Identifier Type: -

Identifier Source: org_study_id