Primary Open Angle GlaucomaNCT01217853
24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry
An observational study of Primary Open Angle Glaucoma, run by Sensimed AG at 2 sites in Germany.
Trial summary
A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- SENSIMED Triggerfish
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2010to Aug 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.
Who may be able to join
- Signed informed consent for the investigation
- Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
- Age 40-70 years at inclusion
- Not more than 4 diopters spherical equivalent on the study eye
- Not more than 2 diopters cylinder equivalent on the study eye
- For women of childbearing potential, adequate contraception
- Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation
Who cannot join
- Patients not able to understand the character and individual consequences of the investigation
- Patients committed to an institution by virtue of an order issued either by the courts or by an authority
- Absence of or withdrawn informed consent
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
- Eye disorders including severe dry eye
Show all 12Show fewer
- Eye disorders secondary to POAG
- Patient who have had ocular surgery within the last 3 months
- Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
- Pregnancy and lactation
- Allergy to oxybuprocaine (ocular anesthesia)
- Simultaneous participation in other clinical research
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Schlosspark-Klinik
Berlin, 14059
Johannes Gutenberg Universitätsklinik Mainz
Mainz, 55131
About this study
Official title: Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry
A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- SENSIMED Triggerfish
- Medical subject headings
- Glaucoma, Open-Angle
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 intraocular pressure 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 one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.
Measured: During 24 hours
Goldmann applanation tonometry values
Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.
Measured: During 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 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionAug 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensimed AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schlossparkklinik
- Investigators
- Carl Erb, Prof, Principal investigator, Schlosspark-Klinik Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217853
- Sponsor's protocol ID
- 09/10
- Status last verified
- Aug 2011
- First submitted
- 7 Oct 2010
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry
- ClinicalTrials.gov ID
- NCT01217853
- Acronym / sponsor ID
- 09/10
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sensimed AGIndustry (pharma, biotech, devices)
- Collaborators
- Schlossparkklinik
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Oct 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.
A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSIMED Triggerfish | – | Device: SENSIMED Triggerfish |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.
Key inclusion criteria (7 listed)
- Signed informed consent for the investigation
- Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
- Age 40-70 years at inclusion
- Not more than 4 diopters spherical equivalent on the study eye
- Not more than 2 diopters cylinder equivalent on the study eye
Key exclusion criteria (12 listed)
- Patients not able to understand the character and individual consequences of the investigation
- Patients committed to an institution by virtue of an order issued either by the courts or by an authority
- Absence of or withdrawn informed consent
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
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 intraocular pressure monitoring | Device | SENSIMED Triggerfish |
Primary outcome
SENSIMED Triggerfish output values
Time frame: During 24 hours
Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.
Goldmann applanation tonometry values
Time frame: During 24 hours
Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.
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 3 Aug 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.
Carl Erb, Prof principal investigator
Schlosspark-Klinik Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Sensimed AG at 2 sites 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 7 inclusion and 12 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 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
SENSIMED Triggerfish output values (time frame: During 24 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 3 Aug 2011.