NCT01946828

Brief Summary

The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm the safety and performance/efficacy of the FIM when exposed to a larger and more varied population of users.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

September 11, 2013

Last Update Submit

September 16, 2013

Conditions

Pupil Dilation

Keywords

Field Induced MydriasisFIMATI

Outcome Measures

Primary Outcomes (2)

  • Safety

    number, severity and causality of unexpected, device related adverse events

    4 months

  • Functionality

    Functionality - ability to perform standard ophthalmologic examination

    4 months

Secondary Outcomes (1)

  • Usability

    4 months

Study Arms (1)

FIM

EXPERIMENTAL

safety and efficacy of the FIM when exposed to a large and varied population of patients and users and operated according to its instructions for use

Device: FIM

Interventions

FIMDEVICE

Field Induced Mydriasis device

FIM

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle.
  • Age 18-45 years old.
  • Willing and able to sign the informed consent, after reading the study information form

You may not qualify if:

  • Any known or diagnosed neurological disorders.
  • A known medical history of ophthalmic surgery or any other disease that might influence the iris control muscle.
  • Volunteers with a narrow or closed angle of the anterior chamber
  • Presence of a corneal pathology which precludes measurement of the pupil dilatation
  • Using of psychiatric medications
  • Pregnancy
  • Recent use (last 48hr) of pupil dilator eye drops.
  • The volunteer is participating in other trials using drugs or devices
  • Drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Links

MeSH Terms

Conditions

Mydriasis

Condition Hierarchy (Ancestors)

Pupil DisordersEye Diseases

Central Study Contacts

Keren El Ogalbo

CONTACT

972-36974165kerenel@tlvmc.gov.il

Adi Gluzberg

CONTACT

+972-52-6401020adi_g@medicsense.om

Study Design

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

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 20, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

IL(1)