GlaucomaNCT02624427
Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer
A study testing Measurement of intraocular pressure (IOP) in people with Glaucoma, run by University of Zurich.
Trial summary
The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Measurement of intraocular pressure (IOP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of glaucoma
- 18 years old or older with no upper limit
- no diagnosis of glaucoma
- 18 years old or older with no upper limit
Who cannot join
- IOP lowering surgery within the last 3 weeks
- any corneal surgery in the past
- bad fixation
- insufficient measurement quality with any of the study devices
- any diagnosis of glaucoma
- IOP lowering surgery within the last 3 weeks
Show all 9Show fewer
- any corneal surgery in the past
- bad fixation
- insufficient measurement quality with any of the study devices
About this study
Official title: Comparison of Intraocular Pressure Measured by Goldmann Applanation Tonometry and Dynamic Contour Tonometry vs. Corvis ST Tonometer
The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.
Read the detailed description
The aim of the study is to approach the "true" Intra ocular pressure (IOP) by correlating the difference between IOP by Goldmann Applanation Tonometry to the IOP by Dynamic Contour Tonometry to the biomechanical parameters of the cornea measured by Corvis ST. Therefore the investigators gain new findings about the influence of the biomechanical corneal parameters on the IOP. In order to do so the investigators want to examine 50 Glaucoma eyes and 50 non-Glaucoma Eyes with Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST.
- Conditions
- Glaucoma
- Being tested
- Measurement of intraocular pressure (IOP)
- Keywords
- Glaucoma, Intraocular Pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of intraocular pressure (IOP)Device
Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Eyes | Experimental | Measurement of intraocular pressure (IOP) Receives: Device: Measurement of intraocular pressure (IOP) |
| Healthy Eyes | Active comparator | age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP) Receives: Device: Measurement of intraocular pressure (IOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta IOP
IOP difference of Goldmann tonometer and Dynamic Contour tonometer
Measured: baseline
Secondary outcomes (1)
Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer
Corvis ST has an integrated high-speed Scheimpflug camera which records images on which basis the biomechanical corneal parameter are analyzed (corneal thickness in micrometers, corneal applications in millimeters, peak distance in millimeters, radius in millimeters, and deformation amplitude in millimeters). Those biomechanical parameters of the cornea will be correlated to the difference of the IOP measured by GAT and by DCT (GAT - DCT).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionNov 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Funk, MD PhD, Principal investigator, UniversityHospital of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624427
- Sponsor's protocol ID
- Corvis and DCT vs. GAT
- Status last verified
- Jun 2017
- First submitted
- 27 Nov 2015
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraocular Pressure Measured by Goldmann Applanation Tonometry and Dynamic Contour Tonometry vs. Corvis ST Tonometer
- ClinicalTrials.gov ID
- NCT02624427
- Acronym / sponsor ID
- Corvis and DCT vs. GAT
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Dec 2015 (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 is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.
Detailed description
The aim of the study is to approach the "true" Intra ocular pressure (IOP) by correlating the difference between IOP by Goldmann Applanation Tonometry to the IOP by Dynamic Contour Tonometry to the biomechanical parameters of the cornea measured by Corvis ST. Therefore the investigators gain new findings about the influence of the biomechanical corneal parameters on the IOP. In order to do so the investigators want to examine 50 Glaucoma eyes and 50 non-Glaucoma Eyes with Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Eyes | Experimental | Device: Measurement of intraocular pressure (IOP)Measurement of intraocular pressure (IOP) |
| Healthy Eyes | Active comparator | Device: Measurement of intraocular pressure (IOP)age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of glaucoma
- 18 years old or older with no upper limit
- no diagnosis of glaucoma
- 18 years old or older with no upper limit
Key exclusion criteria (9 listed)
- IOP lowering surgery within the last 3 weeks
- any corneal surgery in the past
- bad fixation
- insufficient measurement quality with any of the study devices
- any diagnosis of glaucoma
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 |
|---|---|---|
| Measurement of intraocular pressure (IOP)Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer | Device | Glaucoma Eyes, Healthy Eyes |
Primary outcome
Delta IOP
Time frame: baseline
IOP difference of Goldmann tonometer and Dynamic Contour tonometer
1 secondary outcome
Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer
Time frame: baseline
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 21 Jun 2017.
- Study CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure 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
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.
Jens Funk, MD PhD principal investigator
UniversityHospital of Zurich, Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of intraocular pressure (IOP) in people with Glaucoma, run by University of Zurich.
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 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Delta IOP (time frame: baseline). 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 21 Jun 2017.