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

Not Applicable

• Conditions: Pupil Dilation
• Interventions: Device: FIM

• Registration Number: NCT01946828
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Study First Posted: 2013-09-20
• Last Update Posted: 2013-09-20
• Study Start: 2013-10
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FIM	FIM	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Usability	4 months	Device usability and user satisfaction

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel