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Completed

NCT Number: NCT03270865

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorasky Medical Center

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAF (Positioning And Fixation device)

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.

Primary outcomes

  1. spatial location of the pupil, during an eye examination

    Time frame: 1 year

    documentation of pupil location by a camera

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.