An interventional study of FIM in Pupil Dilation, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-20.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable and Interventional
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.
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.
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's planned enrollment of 70 is above the median of 61 across 35 interventional studies indexed under Mydriasis.
Browse Mydriasis studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Safety
number, severity and causality of unexpected, device related adverse events
Time frame: 4 months
Functionality
Functionality - ability to perform standard ophthalmologic examination
Time frame: 4 months
Usability
Device usability and user satisfaction
Time frame: 4 months
The record gives a start of Oct 2013, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center →