Normal-Tension GlaucomaNCT01912599
Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma
A study testing Sensimed Triggerfish and Blood Pressure in people with Normal-Tension Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To study the feasibility of a larger study by determining the tolerability of measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory fashion with automatic devices. Participants: 20 patients with moderate to severe normal tension glaucoma and 20 non-glaucomatous patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal-Tension Glaucoma
- What is being tested?
- Sensimed Triggerfish and Blood Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Patients with normal tension glaucoma
- Age minimum: 18 years
- Willingness to participate in the study and to sign the informed consent form.
- Willingness to complete a screening visit and a study visit, both at the UNC eye clinic.
- Established diagnosis of untreated or medically treated normal tension glaucoma irrespective of blood pressure level. Those currently treated with topical drops will only be included in the study if they accept to stop their medication according to the following plan: 1) Those treated with Alphagan, Combigan or Cosopt (or Trusopt, Azopt, Diamox, Neptazane) will be asked to stop their medication for a week, do the study for 24 hours, and then resume with their medication. 2) Those treated with Timolol or Xalatan (or Travatan, Lumigan) will be asked to stop their drops for one month, do the study for 24 hours, and then resume the medication regimen. The reason for this is that the study aims at investigating the relationship between blood pressure and intraocular pressure in untreated patients either for glaucoma or high blood pressure. The difference in duration of time during which patients will be off their glaucoma medication depends on the time it takes to clear the drug in the system. In both cases, glaucoma medication will be stopped from the day following the screening visit.
- 2) Non-glaucomatous healthy controls
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- Age minimum: 18 years
- Willingness to participate in the study and to sign a consent form
- Willingness to complete a screening visit at UNC eye clinic
- Normal eye examination
Who cannot join
- 1) Patients with normal tension glaucoma
- Age less than 18 years or greater than 80 years.
- Patients with high intraocular pressure (> 21 mmHg).
- Patients who have had any type of glaucoma surgery in the past.
- Non-glaucomatous optic neuropathy.
- Intraocular surgery within the last 3 months.
Show all 27Show fewer
- Patients with uveitis
- Ocular abnormalities preventing measurement of intraocular pressure by applanation
- Patients on medication to treat high blood pressure will not be included in the study.
- Patients with hyperthyroidism
- Patients on medication that may raise blood pressure: i.e. systemic or topical steroids taken for 3 or more years for other chronic conditions; cholesterol lowering medications, specifically cholestyramine (Prevalite or Questran) or colestipol (Colestid); oral contraceptives that contain higher concentrations of estrogen, specifically: Ovral, Ogestrel, Demulen, Ovon, and Ortho-Novum; and the antidepressants trimipramine (Surmontil) and venlafaxine (Effexor).
- Patients on estrogen taken for menopause because it may lower blood pressure
- Patients not willing to stop their glaucoma medication temporarily
- Patients with dry eye disease
- 2) Control Patients
- Age less than 18 years or greater than 80 years.
- Patients with high intraocular pressure (> 21 mmHg).
- Patients who have had any type of glaucoma surgery in the past.
- Non-glaucomatous optic neuropathy.
- Intraocular surgery within the last 3 months.
- Patients with uveitis
- Ocular abnormalities preventing measurement of intraocular pressure by applanation
- Patients on medication to treat high blood pressure will not be included in the study.
- Patients with hyperthyroidism
- Patients on medication that may raise blood pressure: i.e. systemic or topical steroids taken for 3 or more years for other chronic conditions; cholesterol lowering medications, specifically cholestyramine (Prevalite or Questran) or colestipol (Colestid); oral contraceptives that contain higher concentrations of estrogen, specifically: Ovral, Ogestrel, Demulen, Ovon, and Ortho-Novum; and the antidepressants trimipramine (Surmontil) and venlafaxine (Effexor).
- Patients on estrogen taken for menopause because it may lower blood pressure
- Patients with dry eye disease
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27599-7040
About this study
Purpose: To study the feasibility of a larger study by determining the tolerability of measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory fashion with automatic devices.
Participants: 20 patients with moderate to severe normal tension glaucoma and 20 non-glaucomatous patients.
Procedures (methods): Both BP and IOP will be measured automatically in each participant in an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person trained in ambulatory BP monitoring devices. The device will be set up to automatically inflate every 30 minutes during the day and every hour during the night to measure and record the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG, Lausanne, Switzerland); the measurements will be taken and recorded every 10 minutes. The contact lens will be inserted by eye doctors (investigators). Both monitoring devices will be removed the following day.
Read the detailed description
Chart review will be performed to select potential glaucoma participants. These potential participants will be invited to participate in the study, either by phone or face-to-face during scheduled visits.
Control participants will be invited from a registry that contains names of prior research participants who have agreed to be contacted about future studies (participants have worn ambulatory blood pressure monitor or ABPM in the past).
Invited persons who agree to participate in the study will be scheduled for a screening visit at the eye clinic, during which they will learn more about the study. On the day of the screening visit, they will be provided with detailed information about the study, after which they will decide whether or not to participate. If they agree, they will sign the consent form. The screening visit will then be conducted by the research personnel and will take place at the eye clinic in a designated closed office and will include measurement of visual acuity, assessment of the anterior and posterior segments of the eye, measurement of IOP by Goldmann applanation tonometry. If after the screening exam it is determined that they do not qualify for the study, they will be told why they are being excluded. Healthy controls as well as glaucomatous patients not on treatment will be fitted with the BP and IOP monitoring devices. Those who are on glaucoma medication will be asked to stop their medication starting the day following the screening visit for the duration detailed in the inclusion criteria, and be given an appointment for the for IOP and BP measurement. On the appointment day, they will be fitted the BP and IOP monitoring devices. The BP monitor will be set up to take the measurements automatically every 30 min during the day and every hour at night until the next morning. The IOP monitor will take measurements every 10 minutes during the 24-hour period. Both devices are computerized and record all the measurements and reading times. Patients will be required to return to the clinic the next morning for removal of the devices, after which there will be no further visits.
- This study will provide for the first time information on the safety, tolerance, and acceptability of the two devices used together. It will also provide preliminary information on the reasons why people may drop out of the study, and information about the relationship between IOP, BP, and OPP in patients with normal tension glaucoma and in healthy controls.
- IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period. Measurements are taken every 10 min for a total duration of 1 min. The results obtained are presented in an arbitrary unit and not mm Hg. In this study, tonometry will be performed using radiofrequency waves at 27 MHz from the external antenna, which is embedded in the patch applied around the patient's eye.
- Conditions
- Normal-Tension Glaucoma
- Being tested
- Sensimed Triggerfish, Blood Pressure
- Keywords
- Glaucoma, Intraocular Pressure, Blood Pressure
- Medical subject headings
- Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensimed TriggerfishDevice
IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
Blood PressureDevice
Patients in both groups will be fitted with a blood pressure cuff that will measure pressures for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Non-Glaucomatous | Active comparator | Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Receives: Device: Sensimed Triggerfish; Device: Blood Pressure |
| Glaucoma | Active comparator | Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. Receives: Device: Sensimed Triggerfish; Device: Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Pressure
The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Measured: 24 Hours
Intraocular Pressure
The IOP provided is the average of all 144 measurements taken during the 24 hour period.
Measured: 24 Hours
Mean Perfusion Pressure
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Measured: 24 Hours
Diastolic Pressure
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Measured: 24 Hours
Systolic Pressure
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
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 posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Normal-Tension GlaucomaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Sensimed AG
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Mwanza, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912599
- Sponsor's protocol ID
- 12-2514
- Status last verified
- Sep 2014
- First submitted
- 26 Jul 2013
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma
- ClinicalTrials.gov ID
- NCT01912599
- Acronym / sponsor ID
- 12-2514
- Conditions
- Normal-Tension Glaucoma
- Keywords
- Glaucoma, Intraocular Pressure, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Sensimed AG
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To study the feasibility of a larger study by determining the tolerability of measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory fashion with automatic devices.
Participants: 20 patients with moderate to severe normal tension glaucoma and 20 non-glaucomatous patients.
Procedures (methods): Both BP and IOP will be measured automatically in each participant in an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person trained in ambulatory BP monitoring devices. The device will be set up to automatically inflate every 30 minutes during the day and every hour during the night to measure and record the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG, Lausanne, Switzerland); the measurements will be taken and recorded every 10 minutes. The contact lens will be inserted by eye doctors (investigators). Both monitoring devices will be removed the following day.
Detailed description
Chart review will be performed to select potential glaucoma participants. These potential participants will be invited to participate in the study, either by phone or face-to-face during scheduled visits.
Control participants will be invited from a registry that contains names of prior research participants who have agreed to be contacted about future studies (participants have worn ambulatory blood pressure monitor or ABPM in the past).
Invited persons who agree to participate in the study will be scheduled for a screening visit at the eye clinic, during which they will learn more about the study. On the day of the screening visit, they will be provided with detailed information about the study, after which they will decide whether or not to participate. If they agree, they will sign the consent form. The screening visit will then be conducted by the research personnel and will take place at the eye clinic in a designated closed office and will include measurement of visual acuity, assessment of the anterior and posterior segments of the eye, measurement of IOP by Goldmann applanation tonometry. If after the screening exam it is determined that they do not qualify for the study, they will be told why they are being excluded. Healthy controls as well as glaucomatous patients not on treatment will be fitted with the BP and IOP monitoring devices. Those who are on glaucoma medication will be asked to stop their medication starting the day following the screening visit for the duration detailed in the inclusion criteria, and be given an appointment for the for IOP and BP measurement. On the appointment day, they will be fitted the BP and IOP monitoring devices. The BP monitor will be set up to take the measurements automatically every 30 min during the day and every hour at night until the next morning. The IOP monitor will take measurements every 10 minutes during the 24-hour period. Both devices are computerized and record all the measurements and reading times. Patients will be required to return to the clinic the next morning for removal of the devices, after which there will be no further visits.
- This study will provide for the first time information on the safety, tolerance, and acceptability of the two devices used together. It will also provide preliminary information on the reasons why people may drop out of the study, and information about the relationship between IOP, BP, and OPP in patients with normal tension glaucoma and in healthy controls.
- IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period. Measurements are taken every 10 min for a total duration of 1 min. The results obtained are presented in an arbitrary unit and not mm Hg. In this study, tonometry will be performed using radiofrequency waves at 27 MHz from the external antenna, which is embedded in the patch applied around the patient's eye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Glaucomatous | Active comparator | Device: Sensimed Triggerfish, Device: Blood PressurePatients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. |
| Glaucoma | Active comparator | Device: Sensimed Triggerfish, Device: Blood PressurePatients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1) Patients with normal tension glaucoma
- 2) Non-glaucomatous healthy controls
Key exclusion criteria (27 listed)
- 1) Patients with normal tension glaucoma
- 2) Control Patients
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 TriggerfishIOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period. | Device | Glaucoma, Non-Glaucomatous |
| Blood PressurePatients in both groups will be fitted with a blood pressure cuff that will measure pressures for 24 hours. | Device | Glaucoma, Non-Glaucomatous |
Primary outcome
Arterial Pressure
Time frame: 24 Hours
The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Intraocular Pressure
Time frame: 24 Hours
The IOP provided is the average of all 144 measurements taken during the 24 hour period.
Mean Perfusion Pressure
Time frame: 24 Hours
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Diastolic Pressure
Time frame: 24 Hours
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Systolic Pressure
Time frame: 24 Hours
The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean-Claude Mwanza, MD, PhD principal investigator
University of North Carolina, Chapel Hill
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 and Blood Pressure in people with Normal-Tension Glaucoma, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 10 inclusion and 27 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 Jun 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arterial Pressure (time frame: 24 Hours). The study lists 5 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 17 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.