Primary Open-angle Glaucoma (POAG) PatientNCT01828255

Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

A study testing SENSIMED Triggerfish® in people with Primary Open-angle Glaucoma (POAG) Patient, run by Sensimed AG at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. Read more about this study

Who is it for?: Ages 40 to 89 years
Conditions the study is for: Primary Open-angle Glaucoma (POAG) Patient
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: 40 participants
Where: 1 siteUnited States
Study dates: Mar 2013to May 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 40 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 40 and 89 years old
Diagnosis of treated POAG (including normal tension glaucoma (NTG))
All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p<0.01, with at least 1 point at p < 0.005
At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%
For fast progressing eyes, 1) pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year

Show all 9Show fewer

For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above
Not more than 6 diopters spherical equivalent on the study eye
Have given written informed consent, prior to any investigational procedures

Who cannot join

Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
Corneal or conjunctival abnormality precluding contact lens adaptation
Severe dry eye syndrome or other ocular disease
Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
Patients with previous intraocular surgery in the enrolled eye, including cataract surgery
Patients with allergy to corneal anesthetic

Show all 9Show fewer

Patients with contraindications for silicone contact lens wear
Patients not able to understand the character and individual consequences of the investigation
Participation in unrelated clinical research within the last 4 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

The New York Eye and Ear Infirmary
New York, New York, 10003

Other trials in United States

About this study

Official title: A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression

Conditions: Primary Open-angle Glaucoma (POAG) Patient
Being tested: SENSIMED Triggerfish®
Medical subject headings: Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SENSIMED Triggerfish®Device

Study groups in NCT01828255
Study group	Role	What they receive
SENSIMED Triggerfish®	Experimental	Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization. Receives: Device: SENSIMED Triggerfish®

What is being measured

The primary outcome is the main question the study is designed to answer.

Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
Measured: 24-hour

Secondary outcomes (4)

Relationship Between TF Pattern and VF Progression According to TF Slope
Measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression during wake vs sleep periods. The wake slope corresponds to the change in the TF signal from 1 hour before to 1 hour after the time the subject went to sleep. The sleep slope corresponds to the change from 1 hour before to 1 hour after the time the subject awoke.
Measured: 24-hour
Relationship Between TF Pattern and VF Progression According to Day and Night
TF measurement during diurnal and nocturnal periods and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
Measured: 24-hour
Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.
Measured: 24-hour
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
Comparison (Spearman correlations) between 24-hour IOP-related fluctuations measured by TF and 24-hour blood pressure profiles (systolic, diastolic and mean arterial blood pressure) of POAG patients showing fast and slow rates of glaucoma visual field progression. The correlation between TF and blood pressure measurement was calculated within each subject then mean values were obtained for patients with slow vs fast glaucoma visual field progression.
Measured: 24-hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013May 2014

First posted10 Apr 2013 (estimated)
Study startMar 2013
Primary completionMay 2014
Study completionMay 2014

Why it stopped: Low recruitment rate

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 Primary Open-angle Glaucoma (POAG) PatientStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828255
Sponsor's protocol ID: TF-1212
Status last verified: Sep 2020
First submitted: 5 Apr 2013
Last updated: 9 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
Active, not recruitingObservational study
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Primary Open Angle Glaucoma (POAG)

All Primary Open-angle Glaucoma (POAG) Patient trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression
ClinicalTrials.gov ID: NCT01828255
Acronym / sponsor ID: TF-1212
Conditions: Primary Open-angle Glaucoma (POAG) Patient
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low recruitment rate
Enrolment: 40 participants (actual)
Lead sponsor: Sensimed AGIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 10 Apr 2013 (estimated)
Results: Posted 9 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SENSIMED Triggerfish®	Experimental	Device: SENSIMED Triggerfish®Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.

Who may qualify

Ages: 40 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age between 40 and 89 years old
Diagnosis of treated POAG (including normal tension glaucoma (NTG))
All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p<0.01, with at least 1 point at p < 0.005
At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%

Key exclusion criteria (9 listed)

Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
Corneal or conjunctival abnormality precluding contact lens adaptation
Severe dry eye syndrome or other ocular disease
Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
Patients with previous intraocular surgery in the enrolled eye, including cataract 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®	Device	SENSIMED Triggerfish®

Primary outcome

Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
Time frame: 24-hour
24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.

4 secondary outcomes

Relationship Between TF Pattern and VF Progression According to TF Slope
Time frame: 24-hour
Relationship Between TF Pattern and VF Progression According to Day and Night
Time frame: 24-hour
Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
Time frame: 24-hour
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
Time frame: 24-hour

Results and safety

Results posted to the registry on 9 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fast Progressors	20	20
Slow Progressors	20	20

Primary outcome: Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.

Time frame: 24-hour. Mean (Standard Deviation). Unit: mVeq

Measure	Fast Progressors n = 17	Slow Progressors n = 17
Value	410.1 (138.4)	334.6 (119.4)

Population analysed: POAG patients with slow or fast rate of VF glaucoma progression

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fast Progressors	0 of 20 (0%)	1 of 20 (5%)	Not reported
Slow Progressors	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Open-angle Glaucoma (POAG) Patient

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Not yet recruiting
Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
Active, not recruitingObservational study
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Primary Open Angle Glaucoma (POAG)

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.

Gustavo De Moraes, MD principal investigator

The New York Eye and Ear Infirmary

Jeffrey M Liebmann, MD principal investigator

The New York Eye and Ear Infirmary

Robert Ritch, MD principal investigator

The New York Eye and Ear Infirmary

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 (POAG) Patient, run by Sensimed AG 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 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: stopped early, as of the sponsor's last update on 9 Oct 2020. 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 9 Oct 2020). 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?

Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression 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?

On the ClinicalTrials.gov record for NCT01828255.

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 9 Oct 2020.