Primary Open Angle GlaucomaNCT01767753
IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
A study testing Sensimed Triggerfish in people with Primary Open Angle Glaucoma and Pigmentary Glaucoma, run by Sensimed AG at 1 site in France.
Trial summary
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliative 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
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jul 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
- Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB
- No or stable anti-glaucomatous drug therapy since at least 3 months
- Structural and/or functional glaucomatous damage
- Aged more than 18 years, of either sex
- Not more than 6 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
- Refractory glaucoma
- Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
- 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
Show all 9Show fewer
- 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'Ophthalmologie des Quinze-Vingts
Paris, 75012
About this study
Official title: A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.
The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.
- Being tested
- Sensimed Triggerfish
- Keywords
- Glaucoma, SLT
- 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.
To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT.
- Wake-to-Sleep slopes
- Overall variability
- Diurnal and nocturnal IOP patterns
- Number of peaks
Measured: 1 months
Secondary outcomes (2)
To assess IOP patterns of POAG patients during office hours
Overall variability
- Diurnal and nocturnal IOP patterns
- Number of peaks in the study population before and after SLT
Measured: 1 month
Safety and tolerability in this patient population
Adverse events and serious adverse events will be collected throughout the duration of the study
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Nordmann, MD, Principal investigator, Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767753
- Sponsor's protocol ID
- TF-1207
- Status last verified
- Nov 2015
- First submitted
- 10 Jan 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
- ClinicalTrials.gov ID
- NCT01767753
- Acronym / sponsor ID
- TF-1207
- Keywords
- Glaucoma, SLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 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.
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.
The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.
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 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
- Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB
- No or stable anti-glaucomatous drug therapy since at least 3 months
- Structural and/or functional glaucomatous damage
- Aged more than 18 years, of either sex
Key exclusion criteria (9 listed)
- Refractory glaucoma
- Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Patients with allergy to corneal anesthetic
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
To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT.
Time frame: 1 months
* Wake-to-Sleep slopes * Overall variability * Diurnal and nocturnal IOP patterns * Number of peaks
2 secondary outcomes
To assess IOP patterns of POAG patients during office hours
Time frame: 1 month
Safety and tolerability in this patient population
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
Related trials for Primary Open Angle Glaucoma
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
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
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.
Jean-Philippe Nordmann, MD principal investigator
Centre Hospitalier National d'Ophthalmologie 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 and Pigmentary 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 8 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: finished, as of the sponsor's last update on 17 Nov 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT. (time frame: 1 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 17 Nov 2015.