NCT03270865

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

August 15, 2017

Last Update Submit

June 12, 2019

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • spatial location of the pupil, during an eye examination

    documentation of pupil location by a camera

    1 year

Study Arms (1)

Usability and Ergonomic Evaluation of Self-Positioning System

EXPERIMENTAL
Device: PAF (Positioning And Fixation device)

Interventions

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.

Usability and Ergonomic Evaluation of Self-Positioning System

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Visual acuity \>=20/200 in the better eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

September 1, 2017

Study Start

September 30, 2017

Primary Completion

February 1, 2018

Study Completion

September 30, 2018

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

IL(1)