Open Angle GlaucomaNCT03047239
TF for the Prediction of Visual Field Progression
A study testing SENSIMED Triggerfish in people with Open Angle Glaucoma, run by Sensimed AG.
Trial summary
Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural vision tests measured prospectively every 3 months over a 2-year period, will be used to model TF's ability to serve as a risk factor for individual progression rates. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Open Angle 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2023
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For glaucoma subjects, a clinical diagnosis of OAG* in the study eye with an abnormal optic disc defined as:
- diffuse or focal narrowing, or notching, of the optic disc rim, or
- progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc increased cupping of the optic disc, or
- diffuse or localized abnormalities of the parapapillary RNFL, or
- disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages, or
- optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue, or
Show all 21Show fewer
- large extent of parapapillary atrophy and an abnormal VF defined as
- VF damage consistent with RNFL damage (e.g., nasal step, arcuate field defect, or paracentral depression in clusters of test sites) based on the presence of a cluster of 3 or more non-edge points on the pattern deviation plot at p < 5% with 1 point at p < 1%, or
- Glaucoma Hemifield Test (GHT) outside normal limits.
- OAG*:
- Primary open angle glaucoma (POAG; includes normal tension glaucoma (NTG), i.e.: POAG with all known untreated IOP measurements < 22 mmHg using Goldmann applanation tonometry): defined by the presence of open angles on gonioscopy in the absence of other causes of glaucomatous optic neuropathy and VF defects; or
- Exfoliative glaucoma (XFG): defined by the presence of exfoliative material on the pupil border and/or on the surface of the lens capsule except the central zone; or
- Pigmentary glaucoma (PEG): defined by the presence of pigment dispersed on the trabecular meshwork, Schwalbe's line, the iris surface, the lens equator, the corneal endothelium, and/or characteristic trans-illumination defects of the mid-peripheral iris.
- For glaucoma subjects, MD not worse than -12.00 dB at enrollment in the study eye
- For glaucoma subjects, no IOP-lowering treatment or stable IOP-lowering treatment regimen in the study eye in the 3 months prior to the screening visit
- For glaucoma subjects, at least 1 year of experience with VF testing
- For healthy subjects, normal optic disc, normal VF, IOP ≤ 21 mmHg and open anterior chamber angle in the study eye and no known family history of glaucoma
- Best corrected visual acuity (BCVA) 20/25 in the study eye at time of screening
- Aged 22 to 80 years
- Spherical and cylinder equivalent in the study eye between ±6.00 and ±3.00 diopters, respectively
- Having given written informed consent, prior to any investigational procedures
Who cannot join
- Ocular pathology other than glaucoma in the study eye affecting VF test and OCT-RNFL results
- Glaucoma surgery in the study eye prior to the screening visit
- Cataract surgery or glaucoma laser treatment in the study eye within 3 months of the screening visit
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for TF wear: active eye disease, eye injury or eye abnormality affecting the cornea, conjunctiva, or eyelids, subject history of eye or eyelid infections including styes or history of AEs associated with wearing contact lenses, or intolerance, or abnormal ocular response to contact lenses, active inflammation of the eye, active infection of the eye, corneal vascularization, insufficiency of lacrimal secretion, corneal hypoesthesia, known allergy to silicone
- Subjects unable or unwilling to comply with the study procedures and who are unlikely to be able to complete the 24-month follow-up period.
- Participation in other interventional clinical research within the last 4 weeks
About this study
Official title: A Prospective Study Investigating the Relationship Between SENSIMED Triggerfish® Ocular Dimensional Profiles and Disease Progression in Patients With Open Angle Glaucoma
Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural vision tests measured prospectively every 3 months over a 2-year period, will be used to model TF's ability to serve as a risk factor for individual progression rates.
Read the detailed description
Glaucoma subjects will be selected based on scheduled appointments (consecutive selection) and clinic records such as patient databases (convenience selection) and invited to participate in the study. After having signed and dated the informed consent form, they will receive an appointment for a screening visit, during which they will undergo an ophthalmic examination and review of their medical and ophthalmic history as well as prior and current treatments. The eye at higher risk of disease progression will be selected for the study if both eyes are eligible.
On study day 0 (SD0), subjects will receive TF for a 24-hour recording of the profile of ocular dimensional changes, starting between 11 am and 3 pm, with simultaneous recording of 24-hour blood pressure (BP). The recordings will be carried out in ambulatory conditions with the subjects pursuing as close to normal daily activities as possible. Subject activities will be captured in a logbook. After completion of the recording, subjects will receive an ophthalmic exam to exclude or adequately address any side effects and provide the logbook to the investigator.
At 3-month intervals following the TF recording until 2 years after the TF recording, follow-up visits will be scheduled for assessment of the visual field (VF), the retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT), optic disc photo and intraocular pressure (IOP). 24-hour TF recording (starting at the same time as on SD0) will be performed at 1 and 2 years and, if glaucoma subjects undergo a glaucoma surgery in the follow-up period, an additional 24-hour TF profile will be recorded approximately 3 months after the intervention (again starting at the same time as on SD0).
- Conditions
- Open Angle Glaucoma
- 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 TriggerfishDevice
Smart contact lens based device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Open angle glaucoma | Experimental | SENSIMED Triggerfish Receives: Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic odds ratio (DOR) for a SENSIMED Triggerfish based model for the prediction of visual field annual progression rate (24-2 SITA Standard) measured as Mean Deviation (MD) slope
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: strategic change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047239
- Sponsor's protocol ID
- TF-1701
- Status last verified
- May 2025
- First submitted
- 2 Feb 2017
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Investigating the Relationship Between SENSIMED Triggerfish® Ocular Dimensional Profiles and Disease Progression in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT03047239
- Acronym / sponsor ID
- TF-1701
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: strategic change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Feb 2017 (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.
Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural vision tests measured prospectively every 3 months over a 2-year period, will be used to model TF's ability to serve as a risk factor for individual progression rates.
Detailed description
Glaucoma subjects will be selected based on scheduled appointments (consecutive selection) and clinic records such as patient databases (convenience selection) and invited to participate in the study. After having signed and dated the informed consent form, they will receive an appointment for a screening visit, during which they will undergo an ophthalmic examination and review of their medical and ophthalmic history as well as prior and current treatments. The eye at higher risk of disease progression will be selected for the study if both eyes are eligible.
On study day 0 (SD0), subjects will receive TF for a 24-hour recording of the profile of ocular dimensional changes, starting between 11 am and 3 pm, with simultaneous recording of 24-hour blood pressure (BP). The recordings will be carried out in ambulatory conditions with the subjects pursuing as close to normal daily activities as possible. Subject activities will be captured in a logbook. After completion of the recording, subjects will receive an ophthalmic exam to exclude or adequately address any side effects and provide the logbook to the investigator.
At 3-month intervals following the TF recording until 2 years after the TF recording, follow-up visits will be scheduled for assessment of the visual field (VF), the retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT), optic disc photo and intraocular pressure (IOP). 24-hour TF recording (starting at the same time as on SD0) will be performed at 1 and 2 years and, if glaucoma subjects undergo a glaucoma surgery in the follow-up period, an additional 24-hour TF profile will be recorded approximately 3 months after the intervention (again starting at the same time as on SD0).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open angle glaucoma | Experimental | Device: SENSIMED TriggerfishSENSIMED Triggerfish |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For glaucoma subjects, a clinical diagnosis of OAG* in the study eye with an abnormal optic disc defined as:
- For glaucoma subjects, MD not worse than -12.00 dB at enrollment in the study eye
- For glaucoma subjects, no IOP-lowering treatment or stable IOP-lowering treatment regimen in the study eye in the 3 months prior to the screening visit
- For glaucoma subjects, at least 1 year of experience with VF testing
- For healthy subjects, normal optic disc, normal VF, IOP ≤ 21 mmHg and open anterior chamber angle in the study eye and no known family history of glaucoma
Key exclusion criteria (7 listed)
- Ocular pathology other than glaucoma in the study eye affecting VF test and OCT-RNFL results
- Glaucoma surgery in the study eye prior to the screening visit
- Cataract surgery or glaucoma laser treatment in the study eye within 3 months of the screening visit
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for TF wear: active eye disease, eye injury or eye abnormality affecting the cornea, conjunctiva, or eyelids, subject history of eye or eyelid infections including styes or history of AEs associated with wearing contact lenses, or intolerance, or abnormal ocular response to contact lenses, active inflammation of the eye, active infection of the eye, corneal vascularization, insufficiency of lacrimal secretion, corneal hypoesthesia, known allergy to silicone
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 TriggerfishSmart contact lens based device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours | Device | Open angle glaucoma |
Primary outcome
Diagnostic odds ratio (DOR) for a SENSIMED Triggerfish based model for the prediction of visual field annual progression rate (24-2 SITA Standard) measured as Mean Deviation (MD) slope
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIMED Triggerfish in people with Open Angle Glaucoma, run by Sensimed AG.
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 21 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnostic odds ratio (DOR) for a SENSIMED Triggerfish based model for the prediction of visual field annual progression rate (24-2 SITA Standard) measured as Mean Deviation (MD) slope (time frame: 2 years). 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 15 May 2025.