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

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Notal Vision

Status

Completed

Conditions

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

Treatments

Device: PAF (Positioning And Fixation device)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03270865
Notal U-001 V. 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Usability and Ergonomic Evaluation of Self-Positioning System
Experimental group
Treatment:
Device: PAF (Positioning And Fixation device)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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