Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis) (TP 7601-CL)

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Pupil Dilation

Treatments

Device: FIM

Study type

Interventional

Funder types

Other

Identifiers

NCT01946828

TASMC-13-AM-0280-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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