Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
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 Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle.
- •Age 18-45 years old.
- •Willing and able to sign the informed consent, after reading the study information form
Exclusion Criteria
- •Any known or diagnosed neurological disorders.
- •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
Arms & Interventions
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
Intervention: FIM (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Usability(4 months)