NCT03533842

Brief Summary

The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

May 11, 2018

Last Update Submit

August 1, 2018

Conditions

Keywords

TriageAlgorithmsEmergenciesEyes emergenciesOphtalmology

Outcome Measures

Primary Outcomes (1)

  • Comparison between the emergency level defined by iCare and the emergency level decided by the physician at the end of his consultation (gold standard).

    1 hour

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seeking an emergency consultation at the Ophthalmologic emergency unit

You may qualify if:

  • Patients attending the Emergency Room for Ophthalmologic concerns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Instutut Arthur Vernes

Paris, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mikael Guedj

    Institut Arthur Vernes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

March 27, 2018

Primary Completion

June 6, 2018

Study Completion

June 20, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Locations