Pupil DilationTP 7601-CLNCT01946828
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
A study testing FIM in people with Pupil Dilation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupil Dilation
- What is being tested?
- FIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Recent use (last 48hr) of pupil dilator eye drops.
- The volunteer is participating in other trials using drugs or devices
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Keren Elia Ogalbo, +972-36974165, kerenel@tlvmc.gov.il
Adi Gluzberg, +97252-6401020, adi_g@medicsense.com
About this study
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.
Read the 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.
- Conditions
- Pupil Dilation
- Being tested
- FIM
- Keywords
- Field Induced Mydriasis, FIM, ATI
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIMDevice
Field Induced Mydriasis device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: FIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
number, severity and causality of unexpected, device related adverse events
Measured: 4 months
Functionality
Functionality - ability to perform standard ophthalmologic examination
Measured: 4 months
Secondary outcomes (1)
Usability
Device usability and user satisfaction
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupil DilationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946828
- Sponsor's protocol ID
- TASMC-13-AM-0280-CTIL
- Acronym
- TP 7601-CL
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
- ClinicalTrials.gov ID
- NCT01946828
- Acronym / sponsor ID
- TP 7601-CL / TASMC-13-AM-0280-CTIL
- Conditions
- Pupil Dilation
- Keywords
- Field Induced Mydriasis, FIM, ATI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIM | Experimental | Device: FIMsafety 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIMField Induced Mydriasis device | Device | FIM |
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
1 secondary outcome
Usability
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- ATI Advanced Medical TechnologiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIM in people with Pupil Dilation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren El Ogalbo (972-36974165, kerenel@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.