Intraocular PressureNCT00818233
Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
An observational study of Intraocular Pressure, run by Yale University at 1 site in United States.
Trial summary
The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Dynamic contour tonometry
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, competent adults with normal, healthy eyes.
Who may be able to join
- Normal, healthy eyes
- Minimal to moderate refractive error
- Willingness to participate in the study
Who cannot join
- Diagnosis of any type of glaucoma
- Any prior ocular surgery
- Any prior ocular trauma
- Any known anterior segment pathology
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures.
- Conditions
- Intraocular Pressure
- Being tested
- Dynamic contour tonometry
- Keywords
- dynamic contour tonometry, variability, pulse amplitude, Ocular pulse amplitude
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contour tonometryDevice
Also called PASCAL tonometry, DCT
Observe variability of measurements by dynamic contour tonometry
| Study group | Role | What they receive |
|---|---|---|
| Observation | Variability will be assessed between each examiner. Receives: Device: Dynamic contour tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variability of intraocular pressure measurements using dynamic contour tonometry
Measured: Same day
Secondary outcomes (1)
Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures
Measured: Same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2009
Why it stopped: Difficulty recruiting patients. PI left research facility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Hylton R Mayer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818233
- Sponsor's protocol ID
- 0601001047
- Status last verified
- May 2016
- First submitted
- 18 Nov 2008
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
- ClinicalTrials.gov ID
- NCT00818233
- Acronym / sponsor ID
- 0601001047
- Conditions
- Intraocular Pressure
- Keywords
- dynamic contour tonometry, variability, pulse amplitude, Ocular pulse amplitude
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting patients. PI left research facility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 7 Jan 2009 (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 aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Device: Dynamic contour tonometryVariability will be assessed between each examiner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, competent adults with normal, healthy eyes.
Key inclusion criteria (3 listed)
- Normal, healthy eyes
- Minimal to moderate refractive error
- Willingness to participate in the study
Key exclusion criteria (4 listed)
- Diagnosis of any type of glaucoma
- Any prior ocular surgery
- Any prior ocular trauma
- Any known anterior segment pathology
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 |
|---|---|---|
| Dynamic contour tonometryAlso: PASCAL tonometry, DCTObserve variability of measurements by dynamic contour tonometry | Device | Observation |
Primary outcome
The variability of intraocular pressure measurements using dynamic contour tonometry
Time frame: Same day
1 secondary outcome
Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures
Time frame: Same day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Related trials for Intraocular Pressure
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
Recruiting
Glaucoma Screening to Enhance At-Risk Californians' Health
Glaucoma
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
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.
Hylton R Mayer, MD principal investigator
Yale University
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 Intraocular Pressure, run by Yale University at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 May 2016. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
The variability of intraocular pressure measurements using dynamic contour tonometry (time frame: Same day). 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 13 May 2016.