Primary Open Angle GlaucomaNCT01561001
IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy With Collagen Implant
A study testing SENSIMED Triggerfish® in people with Primary Open Angle Glaucoma, run by Sensimed AG at 1 site in Switzerland.
Trial summary
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork 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
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Mar 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 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 DSCI
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork 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 with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.
- Conditions
- Primary 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 Triggerfish®Device
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG.
The IOP fluctuation profile will be recorded by Triggerfish® in patients with POAG
- before DSCI
- 3 months after DSCI.
Measured: 3 months
Secondary outcomes (3)
Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern
Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use
Measured: 3 months
Changes in visual field 3 months after DSCI
Change in the visual field
Measured: 3 months
Safety and tolerability
Adverse events and serious adverse events 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 posted22 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionMar 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinique Monchoisi
- Responsible party
- Sponsor
- Investigators
- André Mermoud, MD, Principal investigator, Clinique Monchoisi, Unité du Glaucome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561001
- Sponsor's protocol ID
- TF-1113
- Status last verified
- May 2015
- First submitted
- 20 Mar 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant
- ClinicalTrials.gov ID
- NCT01561001
- Acronym / sponsor ID
- TF-1113
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinique Monchoisi
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2012 (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 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 with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 DSCI
- Aged ≥18 years, of either sex
- Not more than 4 diopters spherical equivalent on the study eye
Key exclusion criteria (6 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 Triggerfish®Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours. | Device | – |
Primary outcome
Effect of DSCI 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 patients with POAG * before DSCI * 3 months after DSCI.
3 secondary outcomes
Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern
Time frame: 3 months
Changes in visual field 3 months after DSCI
Time frame: 3 months
Safety and tolerability
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
André Mermoud, MD principal investigator
Clinique Monchoisi, Unité du Glaucome
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 Switzerland.
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 6 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 20 May 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 Switzerland. 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 stopped early. Results are not available in the source record.
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 DSCI 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 20 May 2015.