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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIM | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIM | Device | Field Induced Mydriasis device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | number, severity and causality of unexpected, device related adverse events | 4 months |
| Functionality | Functionality - ability to perform standard ophthalmologic examination | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Device usability and user satisfaction | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keren El Ogalbo | Contact | 972-36974165 | kerenel@tlvmc.gov.il | |
| Adi Gluzberg | Contact | +972-52-6401020 | adi_g@medicsense.om |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| Label | URL |
|---|---|
| ATI Advanced Medical Technologies | View source |
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| ID | Term |
|---|---|
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D005128 | Eye Diseases |
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