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

Pupil Dilation Clinical Trial

— TP 7601-CL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01946828
• Other study ID #: TASMC-13-AM-0280-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 11, 2013
• Last updated: September 16, 2013
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Keren El Ogalbo
• Phone: 972-36974165
• Email: kerenel[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: el Aviv Sourasky Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mydriasis
• Pupil Dilation

Intervention

Device:
• FIM
Field Induced Mydriasis device

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	number, severity and causality of unexpected, device related adverse events	4 months	Yes
Primary	Functionality	Functionality - ability to perform standard ophthalmologic examination	4 months	No
Secondary	Usability	Device usability and user satisfaction	4 months	No

External Links

•   ATI Advanced Medical Technologies