Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01946828

Acronym

TP 7601-CL

Enrollment

Registered

2013-09-20

Start date

2013-10-31

Completion date

2014-02-28

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupil Dilation

Keywords

Field Induced Mydriasis, FIM, ATI

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.

Detailed description

70 Eligible subjects will be enrolled to the study and examined with the FIM to determine the degree of pupil dilation/Contraction resistance. The study will be conducted in two main stages: 1) pupil dilation measuring and 2) functional examination. The tests' sequence will be randomized, at least 30 minutes between each test.

Interventions

DEVICEFIM

Field Induced Mydriasis device

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Functionality	4 months	Functionality - ability to perform standard ophthalmologic examination
Safety	4 months	number, severity and causality of unexpected, device related adverse events

Secondary

Measure	Time frame	Description
Usability	4 months	Device usability and user satisfaction

Countries

Israel

Contacts

Primary ContactKeren El Ogalbo

kerenel@tlvmc.gov.il972-36974165

Backup ContactAdi Gluzberg

adi_g@medicsense.om+972-52-6401020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026