Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis) (TP 7601-CL)

September 16, 2013 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: FIM
Field Induced Mydriasis device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: 4 months
Device usability and user satisfaction
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-AM-0280-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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