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

AMD Population - Intermediate or Advanced AMD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270865
• Other study ID #: Notal U-001 V. 1.0
• Status: Completed
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: June 2019
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 30, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Sorasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spatial location of the pupil, during an eye examination	documentation of pupil location by a camera	1 year