GlaucomaNCT01906151
IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
A study testing SENSIMED Triggerfish® in people with Glaucoma, run by Sensimed AG at 1 site in France.
Trial summary
The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- Jan 2014to 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 Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
- No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Who cannot join
- History of acute angle closure glaucoma on the study eye
- Secondary angle closure glaucoma on the study eye
- History of ocular surgery within the last 3 months on the study eye
- History of ocular laser treatment, including previous LPI on the study eye
- Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
- Severe dry eye syndrome on the study eye
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy
The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients
- Conditions
- Glaucoma
- Being tested
- SENSIMED Triggerfish®
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED Triggerfish®Device
SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
| Study group | Role | What they receive |
|---|---|---|
| SENSIMED Triggerfish® | Other | SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna 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.
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
Measured: 24 hours
Secondary outcomes (2)
To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma
Measured: 24 hours
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma
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 posted23 Jul 2013 (estimated)
- Study startJan 2014
- 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 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
- Investigators
- Christophe Baudouin, MD, Principal investigator, CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906151
- Sponsor's protocol ID
- TF-1306
- Status last verified
- May 2014
- First submitted
- 19 Jul 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 Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy
- ClinicalTrials.gov ID
- NCT01906151
- Acronym / sponsor ID
- TF-1306
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Jul 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.
The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients
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® | Other | Device: SENSIMED Triggerfish®SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
- No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
- Aged ≥18 years, of either sex
- Not more than 6 diopters spherical equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures
Key exclusion criteria (9 listed)
- History of acute angle closure glaucoma on the study eye
- Secondary angle closure glaucoma on the study eye
- History of ocular surgery within the last 3 months on the study eye
- History of ocular laser treatment, including previous LPI on the study eye
- Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
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®SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization | Device | SENSIMED Triggerfish® |
Primary outcome
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
Time frame: 24 hours
2 secondary outcomes
To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma
Time frame: 24 hours
To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma
Time frame: 24 hours
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
CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France
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 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 5 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: 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?
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy (time frame: 24 hours). 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.