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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
70
Field Induced Mydriasis device
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
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
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