Clinical Trial: Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Usability [ Time Frame: 4 months ]

Device usability and user satisfaction


Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: September 11, 2013
Date Started: October 2013
Date Completion: February 2014
Last Updated: September 16, 2013
Last Verified: September 2013