Primary Open Angle GlaucomaNCT01769521
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
A study testing Sensimed Triggerfish® in people with Primary Open Angle Glaucoma and Normal Tension Glaucoma, run by Sensimed AG at 1 site in Poland.
Trial summary
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Normal Tension Glaucoma
- What is being tested?
- Sensimed Triggerfish®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2012to Apr 2013
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of POAG, including progressing normal tension glaucoma (NTG) based on recent or recurrent disc haemorrhage
- No anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to SD0 and absent throughout the study
- Aged more than 18 years, of either sex
- Not more than 4 diopters spherical equivalent on both eyes
- Not more than 2 diopters cylinder equivalent on both eyes
- Have given written informed consent, prior to pre-study screening
Who cannot join
- Patients with history of ocular surgery within the last 3 months
- Corneal or conjunctival abnormality hindering contact lens adaptation
- Severe dry eye
- Secondary forms of OAG
- Patients with systemic hypertension
- Patients with allergy to corneal anesthetic
Show all 10Show fewer
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during Triggerfish® monitoring
- Patients not able to understand the character and individual consequences of the investigation
- Simultaneous participation in other clinical research
Trial locations and contacts
1 site in 1 country.
Poland1 site
Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski
Poznan, 61-848
About this study
Official title: A Single Center, Prospective, Open Label Study Assessing the Relationship Between the 24-hour Intraocular Pressure Pattern as Determined by Sensimed Triggerfish® and the 24-hour Blood Pressure Pattern in Patients With Primary Open Angle Glaucoma
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated.
The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
- Being tested
- Sensimed Triggerfish®
- Keywords
- Glaucoma, IOP, Blood pressure, ECG
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensimed Triggerfish®Device
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
| Study group | Role | What they receive |
|---|---|---|
| Triggerfish | Experimental | Device: Sensimed Triggerfish Receives: Device: Sensimed Triggerfish® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG.
Measured: 24-hour
Secondary outcomes (5)
Nycthemeral IOP pattern
The nycthemeral IOP fluctuation pattern, will be derived from the Triggerfish®, over a 24-hour period. Curves will be plotted for the IOP fluctuation.
Measured: 24-hour
Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)
The nocturnal IOP fluctuation pattern will be compared to that of the diurnal fluctuation pattern (office hours). The diurnal IOP fluctuation pattern will be compared to the tonometric IOP curve concomitantly assessed in the contralateral eye.
Measured: 24 hours
Relationship between intraocular pulsation amplitude and BP
The relationship between intraocular pulsation amplitude and BP will be determined by the determination of the mean intraocular Triggerfish output (IOT), SIOT and DIOT and correlated to the mean BP, SBP and DBP.
Measured: 24-hours
Relationship between the intraocular pulsation frequency and heart rate (HR)
The relationship between the intraocular pulsation frequency as determined by Triggerfish® will be correlated with the heart frequency as determined by ECG
Measured: 24-hours
Assess safety and tolerability
AEs and SAEs will be collected throughout the duration of the study
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
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
- Allocation
- Not applicable
- 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)
- Responsible party
- Sponsor
- Investigators
- Jarosław Kocięcki, MD, Principal investigator, Przemienienia Pańskiego Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769521
- Sponsor's protocol ID
- TF-1011
- Status last verified
- Nov 2015
- First submitted
- 10 Jan 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Open Label Study Assessing the Relationship Between the 24-hour Intraocular Pressure Pattern as Determined by Sensimed Triggerfish® and the 24-hour Blood Pressure Pattern in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01769521
- Acronym / sponsor ID
- TF-1011
- Keywords
- Glaucoma, IOP, Blood pressure, ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Jan 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.
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated.
The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triggerfish | Experimental | Device: Sensimed Triggerfish®Device: Sensimed Triggerfish |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of POAG, including progressing normal tension glaucoma (NTG) based on recent or recurrent disc haemorrhage
- No anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to SD0 and absent throughout the study
- Aged more than 18 years, of either sex
- Not more than 4 diopters spherical equivalent on both eyes
- Not more than 2 diopters cylinder equivalent on both eyes
Key exclusion criteria (10 listed)
- Patients with history of ocular surgery within the last 3 months
- Corneal or conjunctival abnormality hindering contact lens adaptation
- Severe dry eye
- Secondary forms of OAG
- Patients with systemic hypertension
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®Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours | Device | Triggerfish |
Primary outcome
To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG.
Time frame: 24-hour
5 secondary outcomes
Nycthemeral IOP pattern
Time frame: 24-hour
Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)
Time frame: 24 hours
Relationship between intraocular pulsation amplitude and BP
Time frame: 24-hours
Relationship between the intraocular pulsation frequency and heart rate (HR)
Time frame: 24-hours
Assess safety and tolerability
Time frame: 24-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 Nov 2015.
Related trials for Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
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.
Jarosław Kocięcki, MD principal investigator
Przemienienia Pańskiego Hospital
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 Primary Open Angle Glaucoma and Normal Tension Glaucoma, run by Sensimed AG at 1 site in Poland.
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 6 inclusion and 10 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 Nov 2015. 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 Poland. 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?
To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG. (time frame: 24-hour). 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 Nov 2015.