Primary Open Angle GlaucomaNCT01766947
IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy
A study testing Sensimed Triggerfish in people with Primary Open Angle Glaucoma, run by Sensimed AG at 1 site in France.
Trial summary
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Mar 2014
- 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
- Diagnosis of POAG
- Documented glaucomatous VF damage with mean defect (MD) > 3 dB
- Progressing glaucomatous damage justifying a DS
- Aged ≥18 years, of either sex
- Not more than 4 diopters spherical equivalent on the study eye
- Not more than 2 diopters cylinder equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Who cannot join
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Patients with allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
- Patients not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Any other contra-indication listed in the Triggerfish user manual
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier National d'Opthalmology des Quinze-Vingts
Paris, 75571
About this study
Official title: A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.
The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Sensimed Triggerfish
- Keywords
- Glaucoma, Deep sclerectomy
- 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 TriggerfishDevice
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.
Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.
The IOP fluctuation profile will be recorded by Triggerfish in patient with POAG
- Before DS
- 3 months after DS
Measured: 3 months
Secondary outcomes (3)
effect of DS on the diurnal and nocturnal IOP fluctuation pattern
Diurnal and nocturnal IOP fluctuation pattern The wake/sleep and sleep/wake Triggerfish slopes Timing of Triggerfish acrophase
Measured: 3 months
Changes in visual field up to 6 months after DS
Change in the visual field
Measured: 3 months
Safety and Tolerability
Adverse events and serious adverse events will be collected throughout the duration of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Baudouin, MD, Principal investigator, Centre hosptilatier National d'Opthalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766947
- Sponsor's protocol ID
- TF-1206
- Status last verified
- May 2014
- First submitted
- 10 Jan 2013
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy
- ClinicalTrials.gov ID
- NCT01766947
- Acronym / sponsor ID
- TF-1206
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Glaucoma, Deep sclerectomy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 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.
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.
The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triggerfish | Experimental | Device: Sensimed TriggerfishDevice : Sensimed Triggerfish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of POAG
- Documented glaucomatous VF damage with mean defect (MD) > 3 dB
- Progressing glaucomatous damage justifying a DS
- Aged ≥18 years, of either sex
- Not more than 4 diopters spherical equivalent on the study eye
Key exclusion criteria (7 listed)
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Patients with allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
- Patients not able to understand the character and individual consequences of the investigation
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 TriggerfishPortable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours | Device | Triggerfish |
Primary outcome
Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.
Time frame: 3 months
The IOP fluctuation profile will be recorded by Triggerfish in patient with POAG * Before DS * 3 months after DS
3 secondary outcomes
effect of DS on the diurnal and nocturnal IOP fluctuation pattern
Time frame: 3 months
Changes in visual field up to 6 months after DS
Time frame: 3 months
Safety and Tolerability
Time frame: 3 months
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 13 May 2014.
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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.
Christophe Baudouin, MD principal investigator
Centre hosptilatier National d'Opthalmologie des Quinze-Vingts
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, run by Sensimed AG at 1 site in France.
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 7 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 13 May 2014. 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 France. 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 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?
Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG. (time frame: 3 months). 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 13 May 2014.