Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
NCT ID: NCT01946828
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2013-10-31
2014-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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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
FIM
Field Induced Mydriasis device
Interventions
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FIM
Field Induced Mydriasis device
Eligibility Criteria
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Inclusion Criteria
* Age 18-45 years old.
* Willing and able to sign the informed consent, after reading the study information form
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Keren Elia Ogalbo
Role: primary
Adi Gluzberg
Role: backup
Related Links
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ATI Advanced Medical Technologies
Other Identifiers
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TASMC-13-AM-0280-CTIL
Identifier Type: -
Identifier Source: org_study_id