Pupil Dilation Clinical Trial
Official title:
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label