Healthy SubjectsNCT01347229
SENSIMED Triggerfish® in Sitting and Supine Position
A study testing SENSIMED Triggerfish® in people with Healthy Subjects, run by Sensimed AG at 1 site in Israel.
Trial summary
The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SENSIMED Triggerfish®
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Apr 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able to provide informed consent
- Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism
- No more than 4 diopters spherical equivalent
- No more than 2 diopters cylinder equivalent
- GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP > 21 mmHg
- GAT IOP difference between eyes within 1 mmHg during initial exam
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- GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam
- ≥ 18 years
- For women with childbearing potential, adequate contraception
Who cannot join
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- History of eye surgery
- Full frame metal glasses during SENSIMED Triggerfish® recording
Show all 9Show fewer
- Known hypersensitivity to silicone, plaster or ocular anesthesia
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers
The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.
Read the detailed description
20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.
- Conditions
- Healthy Subjects
- Being tested
- SENSIMED Triggerfish®
- Keywords
- Glaucoma, Triggerfish, body position
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED Triggerfish®Device
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence
Measured: 45 minutes
Secondary outcomes (3)
Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine
Measured: 30 minutes
IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position
Measured: 2 hours
Monitoring with study device obtained before Day 2
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yaniv Barkana, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347229
- Sponsor's protocol ID
- 10/06
- Status last verified
- Apr 2012
- First submitted
- 2 May 2011
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers
- ClinicalTrials.gov ID
- NCT01347229
- Acronym / sponsor ID
- 10/06
- Conditions
- Healthy Subjects
- Keywords
- Glaucoma, Triggerfish, body position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 May 2011 (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 purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.
Detailed description
20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is able to provide informed consent
- Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism
- No more than 4 diopters spherical equivalent
- No more than 2 diopters cylinder equivalent
- GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP > 21 mmHg
Key exclusion criteria (9 listed)
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- History of eye surgery
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 |
|---|---|---|
| SENSIMED Triggerfish®Soft contact lens-based device for the continuous monitoring of IOP fluctuations | Device | – |
Primary outcome
Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence
Time frame: 45 minutes
3 secondary outcomes
Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine
Time frame: 30 minutes
IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position
Time frame: 2 hours
Monitoring with study device obtained before Day 2
Time frame: 20 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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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.
Yaniv Barkana, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish® in people with Healthy Subjects, run by Sensimed AG 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 9 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: finished, as of the sponsor's last update on 17 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence (time frame: 45 minutes). 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 17 Apr 2012.