Glaucoma09/08NCT01210963
Central Corneal Thickness With SENSIMED Triggerfish
An observational study of Glaucoma and Ocular Hypertension, run by Sensimed AG at 1 site in Germany.
Trial summary
Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- SENSIMED Triggerfish
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).
Who may be able to join
- glaucoma and ocular hypertension scheduled for overnight hospitalisation
- stable IOP-lowering treatment since at least 4 weeks before study
- at least 18 years
- having provided informed consent
Who cannot join
- contact lens wear within the last 2 years
- contraindication for silicone lean wear
- corneal abnormality in either eye
- ocular infection or inflammation
- history of ocular surgery within the last 3 months
- full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
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- pregnancy and lactation
- patients not able to understand the nature of the research
- patients under tutelage
- patients committed to an institution by virtue of an order issued either by the courts or by an authority
- simultaneous participation in other clinical research
Trial locations and contacts
1 site in 1 country.
Germany1 site
Augen- und Poliklinik, Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish
Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- SENSIMED Triggerfish
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIMED TriggerfishDevice
Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation
| 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.
Pachymetry (central corneal thickness)
Measured: after 8 hours nocturnal continuous IOP monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Klink, PD Dr. med, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210963
- Sponsor's protocol ID
- 09/08
- Acronym
- 09/08
- Status last verified
- Mar 2011
- First submitted
- 27 Sep 2010
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish
- ClinicalTrials.gov ID
- NCT01210963
- Acronym / sponsor ID
- 09/08 / 09/08
- Conditions
- Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Sep 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.
Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).
Key inclusion criteria (4 listed)
- glaucoma and ocular hypertension scheduled for overnight hospitalisation
- stable IOP-lowering treatment since at least 4 weeks before study
- at least 18 years
- having provided informed consent
Key exclusion criteria (11 listed)
- contact lens wear within the last 2 years
- contraindication for silicone lean wear
- corneal abnormality in either eye
- ocular infection or inflammation
- history of ocular surgery within the last 3 months
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 Sensor with recording system for continuous monitoring of IOP fluctuation | Device | SENSIMED Triggerfish |
Primary outcome
Pachymetry (central corneal thickness)
Time frame: after 8 hours nocturnal continuous IOP monitoring
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 18 Mar 2011.
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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.
Thomas Klink, PD Dr. med principal investigator
Wuerzburg University Hospital
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 and Ocular Hypertension, run by Sensimed AG at 1 site in Germany.
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 4 inclusion and 11 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 18 Mar 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 Germany. 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?
Pachymetry (central corneal thickness) (time frame: after 8 hours nocturnal continuous IOP monitoring). 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 18 Mar 2011.