GlaucomaNCT01467453
Clinical Application of Sensimed Triggerfish Sensor (TS) With Wireless Signal Transmission for Continuous Intraocular Pressure Measurement
An observational study of Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours. Trial with medical device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Triggerfish
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a diagnosis of glaucoma
Who may be able to join
- Clinical diagnosis of glaucoma
Who cannot join
- Other opticus neuropathy than glaucoma
- Corneal abnormalities (e.g. scaring)
- Dry eye disease
Trial locations and contacts
1 site in 1 country.
About this study
The study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours.
- Trial with medical device
- Conditions
- Glaucoma
- Being tested
- Triggerfish
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriggerfishDevice
Also called Triggerfish, SENSIMED AG, Route de Chavannes 37, 1007 Lausanne, Switzerland
The Triggerfish is a contact lens with an embedded sensor to track changes in intraocular pressure during a period of 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Study completionDec 2012
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.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichChristoph Kniestedt, Assistant Prof, MD, Principal investigator, University Hospital Zurich, Ophtalmic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467453
- Sponsor's protocol ID
- Triggerfisch-001
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Sensimed Triggerfish Sensor (TS) With Wireless Signal Transmission for Continuous Intraocular Pressure Measurement
- ClinicalTrials.gov ID
- NCT01467453
- Acronym / sponsor ID
- Triggerfisch-001
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2011
- Study completion
- Dec 2012
- First posted
- 8 Nov 2011 (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 study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours.
- Trial with medical device
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a diagnosis of glaucoma
Key inclusion criteria (1 listed)
- Clinical diagnosis of glaucoma
Key exclusion criteria (3 listed)
- Other opticus neuropathy than glaucoma
- Corneal abnormalities (e.g. scaring)
- Dry eye disease
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 |
|---|---|---|
| TriggerfishAlso: Triggerfish, SENSIMED AG, Route de Chavannes 37, 1007 Lausanne, SwitzerlandThe Triggerfish is a contact lens with an embedded sensor to track changes in intraocular pressure during a period of 24 hours. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Christoph Kniestedt, Assistant Prof, MD principal investigator
University Hospital Zurich, Ophtalmic Clinic
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 Glaucoma, run by University of Zurich 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2011. 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?
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.
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 16 Nov 2011.