Pigmentary Dispersion SyndromeNCT01253109
Continuous Intraocular Pressure (IOP) Monitoring in Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients
An observational study of Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients, run by Sensimed AG at 1 site in Switzerland.
Trial summary
This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pigmentary Dispersion Syndrome, Pigmentary Glaucoma Patients
- What is being tested?
- SENSIMED Triggerfish
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to Nov 2011
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
Who may be able to join
- Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
- IOP of ≥ 15 mmHg
- 18-60 years.
- Patients able to jog continuously for at least 25 minutes
- Phakic eyes
- Patients who accept signing an informed consent approved by the Ethics Committee.
Who cannot join
- Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
- Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
- Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
- Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
- Patients not able to understand the nature of the research
- Patients under tutorship
Show all 14Show fewer
- Corneal abnormality
- Subjects with contraindications for wearing contact lenses
- Full frame metal glasses during SENSIMED Triggerfish® monitoring
- History of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures
- Ocular inflammation or infection
- History of cardiac or pulmonary disorder
- Pregnancy and lactation
- Simultaneous participation in other clinical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients
This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.
- Being tested
- SENSIMED Triggerfish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED TriggerfishDevice
Contact lens-based device for continuous IOP monitoring
| Study group | Role | What they receive |
|---|---|---|
| SENSIMED Triggerfish | Not described Receives: Device: SENSIMED Triggerfish |
What is being measured
The primary outcome is the main question the study is designed to answer.
SENSIMED Triggerfish output values
Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation
Measured: during 4 to 6 hours
Goldmann Applanation Tonometry values
GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring
Measured: During 4 to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary Dispersion SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Private practicioner, Dr Sunaric Mégevand, Orasis, AugenZentrum Pajic
- Investigators
- Gordana Sunaric Megevand, Dr, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253109
- Sponsor's protocol ID
- 09/11
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01253109
- Acronym / sponsor ID
- 09/11
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- Private practicioner, Dr Sunaric Mégevand, Orasis, AugenZentrum Pajic
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Dec 2010 (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.
This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSIMED Triggerfish | – | Device: SENSIMED Triggerfish |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
Key inclusion criteria (6 listed)
- Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
- IOP of ≥ 15 mmHg
- 18-60 years.
- Patients able to jog continuously for at least 25 minutes
- Phakic eyes
Key exclusion criteria (14 listed)
- Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
- Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
- Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
- Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
- Patients not able to understand the nature of the research
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 TriggerfishContact lens-based device for continuous IOP monitoring | Device | SENSIMED Triggerfish |
Primary outcome
SENSIMED Triggerfish output values
Time frame: during 4 to 6 hours
Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation
Goldmann Applanation Tonometry values
Time frame: During 4 to 6 hours
GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring
Results and safety
The study was stopped early (reason given: Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Pigmentary Dispersion Syndrome, Pigmentary Dispersion Glaucoma
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Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
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.
Gordana Sunaric Megevand, Dr principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients, 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 6 inclusion and 14 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 24 Jan 2012. 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 (reason given: Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.). 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?
SENSIMED Triggerfish output values (time frame: during 4 to 6 hours). The study lists 2 primary outcomes in all. 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 24 Jan 2012.