Primary Open Angle GlaucomaNCT01391078
Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry
A study testing Sensimed Triggerfish Sensor and Goldmann Applanation Tonometry, Perkins Tonometry in people with Primary Open Angle Glaucoma, run by Katrin Lorenz at 1 site in Germany.
Trial summary
This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Sensimed Triggerfish Sensor and Goldmann Applanation Tonometry, Perkins Tonometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to comply with the study procedure
- Patient must be ≥ 18 years old
- Diagnosis of primary open angle glaucoma (EGS criteria)
- Similar behaviour of IOP in both eyes in former IOP profiles
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- Visual Acuity of 20/200 or better in both eyes
- Ability of subject to understand the character and individual consequences of the study
- For women with childbearing potential, adequate contraception
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz
Mainz, RLP, 55131
About this study
Official title: Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients
This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Sensimed Triggerfish Sensor, Goldmann Applanation Tonometry, Perkins Tonometry
- Keywords
- glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensimed Triggerfish SensorDevice
IOP will be monitored for 24 hours
Goldmann Applanation Tonometry, Perkins TonometryDevice
IOP will be measured every two hours within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Sensimed Triggerfish | Experimental | Not described Receives: Device: Sensimed Triggerfish Sensor |
| Goldmann Applanation Tonometry/Perkins Tonometry | Active comparator | Not described Receives: Device: Goldmann Applanation Tonometry, Perkins Tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of GAT/Perkins with TF in a cross-over regression analysis.
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Measured: 48 hours
Secondary outcomes (5)
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Measured: 48 hours
Correlation of IOP profile (GAT) right versus left eye
Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)
Measured: 48 hours
Correlation of IOP profile (TF) right versus left eye
Correlation of TF data right and left eye (mean, min, max, fluctuation)
Measured: 48 hours
Correlation of IOP with blood pressure
Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)
Measured: 48 hours
Correlation of IOP with heart rate
Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katrin Lorenz
- Sponsor type
- University, hospital or other
- Collaborators
- Sensimed AG
- Responsible party
- Sponsor-investigator, Katrin Lorenz, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391078
- Sponsor's protocol ID
- Sensimed Triggerfish11/01
- Status last verified
- Nov 2012
- First submitted
- 14 Jun 2011
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01391078
- Acronym / sponsor ID
- Sensimed Triggerfish11/01
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Katrin LorenzUniversity, hospital or other
- Collaborators
- Sensimed AG
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jul 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.
This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensimed Triggerfish | Experimental | Device: Sensimed Triggerfish Sensor |
| Goldmann Applanation Tonometry/Perkins Tonometry | Active comparator | Device: Goldmann Applanation Tonometry, Perkins Tonometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is able to comply with the study procedure
- Patient must be ≥ 18 years old
- Diagnosis of primary open angle glaucoma (EGS criteria)
- Similar behaviour of IOP in both eyes in former IOP profiles
- Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
Key exclusion criteria (0 listed)
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 SensorIOP will be monitored for 24 hours | Device | Sensimed Triggerfish |
| Goldmann Applanation Tonometry, Perkins TonometryIOP will be measured every two hours within 24 hours | Device | Goldmann Applanation Tonometry/Perkins Tonometry |
Primary outcome
Relation of GAT/Perkins with TF in a cross-over regression analysis.
Time frame: 48 hours
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
5 secondary outcomes
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)
Time frame: 48 hours
Correlation of IOP profile (GAT) right versus left eye
Time frame: 48 hours
Correlation of IOP profile (TF) right versus left eye
Time frame: 48 hours
Correlation of IOP with blood pressure
Time frame: 48 hours
Correlation of IOP with heart rate
Time frame: 48 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 28 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sensor and Goldmann Applanation Tonometry, Perkins Tonometry in people with Primary Open Angle Glaucoma, run by Katrin Lorenz at 1 site in Germany.
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 8 inclusion and 0 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 28 Nov 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 Germany. 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?
Relation of GAT/Perkins with TF in a cross-over regression analysis. (time frame: 48 hours). 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 28 Nov 2012.