Intraocular PressurePhase 4DCTNCT01579331
Reliability of Dynamic Contour Tonometry (DCT)
A Phase 4 study testing DCT (PASCAL© Tonometer) IOP and OPA measurement in people with Intraocular Pressure and Central Corneal Thickness, run by University of Catanzaro at 1 site in Italy.
Trial summary
Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Central Corneal Thickness
- What is being tested?
- DCT (PASCAL© Tonometer) IOP and OPA measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Sep 2012
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects giving a valid consent to be included in this experimentation
- age between 18 and 80 years
- best corrected visual acuity (BCVA) of at least 20/100
- refraction ranging from -6 to +6 dioptres, with an astigmatism ranging from -2 to +2 dioptres
Who cannot join
- History of refractive surgery or any keratoplasty procedure.
- Corneal opacities or diseases making no suitable applanation tonometry.
- Use of contact lenses. History of glaucoma or ocular hypertension.
- History of diabetic retinopathy staged as severe non-proliferative or worse.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Catanzaro - Eye Department
Catanzaro, Catanzaro, 88100
About this study
Official title: Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry
Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique.
Read the detailed description
Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate eventual differences among the measurements.
A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT.
At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.
After 3 weeks observers will contact patients to record eventual adverse events. If examiners consider it as necessary, a safety ophthalmological evaluation will then be performed.
- Conditions
- Intraocular Pressure, Central Corneal Thickness
- Being tested
- DCT (PASCAL© Tonometer) IOP and OPA measurement
- Keywords
- IOP, Tonometry, Pascal, Goldmann, DCT, Dynamic Contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCT (PASCAL© Tonometer) IOP and OPA measurementDevice
Also called Goldmann Applanation Tonometry (AT900© - Haag-Streit AG, Koeniz, Switzerland), Dynamic Contour Tonometry (PASCAL© Tonometer - Ziemer Ophthalmic Systems AG, Port, Switzerland), Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).
Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will undergo a series of 5 Dynamic contour tonometries to evaluate eventual differences among measurements.
Patients will be controlled for 30 days. A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT. At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Contour Tonometry | Experimental | All recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements. Receives: Device: DCT (PASCAL© Tonometer) IOP and OPA measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP expressed in mmHg
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of IOP. Coefficient of Variation will also be calculated).
Measured: measurements will be taken in a single day, in approximately 30 minutes.
OPA expressed in mmHg
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of OPA. Coefficient of Variation will also be calculated).
Measured: measurements will be taken in a single day, in approximately 30 minutes.
Secondary outcomes (2)
IOP difference (expressed in mmHG) between first GAT and DCT
The diurnal tonometric curve (i.e. IOP at 9am, noon, 4pm) will be measured using GAT.
After 1 to 7 days, 5 different IOP measurements recorded every 2 minutes (+/- 1) will be measured at 9am (+/- 15 minutes) using DCT. The difference between GAT and DCT values will be calculated.
Measured: partecipants will undergo a GAT diurnal tonometric curve (one day duration) and after one to seven days will undergo 5 DCT (approx. duration 30 minutes)
IOP difference (expressed in mmHG) between DCT and last GAT
5 different IOP measurements recorded every 2 minutes (+/- 1) will be measured at 9am (+/- 15 minutes) using DCT. After 1-2 minutes a single GAT measurement will be recorded. The difference between GAT and DCT values will be calculated.
Measured: partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionSep 2012
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Varano, MD - Principal Investigator, University of Catanzaro
- Investigators
- Luigi Varano, M. D., Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579331
- Sponsor's protocol ID
- DCT01
- Acronym
- DCT
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry
- ClinicalTrials.gov ID
- NCT01579331
- Acronym / sponsor ID
- DCT / DCT01
- Conditions
- Intraocular Pressure, Central Corneal Thickness
- Keywords
- IOP, Tonometry, Pascal, Goldmann, DCT, Dynamic Contour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Apr 2012 (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.
Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique.
Detailed description
Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate eventual differences among the measurements.
A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT.
At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.
After 3 weeks observers will contact patients to record eventual adverse events. If examiners consider it as necessary, a safety ophthalmological evaluation will then be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Contour Tonometry | Experimental | Device: DCT (PASCAL© Tonometer) IOP and OPA measurementAll recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy subjects giving a valid consent to be included in this experimentation
- age between 18 and 80 years
- best corrected visual acuity (BCVA) of at least 20/100
- refraction ranging from -6 to +6 dioptres, with an astigmatism ranging from -2 to +2 dioptres
Key exclusion criteria (4 listed)
- History of refractive surgery or any keratoplasty procedure.
- Corneal opacities or diseases making no suitable applanation tonometry.
- Use of contact lenses. History of glaucoma or ocular hypertension.
- History of diabetic retinopathy staged as severe non-proliferative or worse.
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 |
|---|---|---|
| DCT (PASCAL© Tonometer) IOP and OPA measurementAlso: Goldmann Applanation Tonometry (AT900© - Haag-Streit AG, Koeniz, Switzerland), Dynamic Contour Tonometry (PASCAL© Tonometer - Ziemer Ophthalmic Systems AG, Port, Switzerland), Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will undergo a series of 5 Dynamic contour tonometries to evaluate eventual differences among measurements. Patients will be controlled for 30 days. A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT. At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve. | Device | Dynamic Contour Tonometry |
Primary outcome
IOP expressed in mmHg
Time frame: measurements will be taken in a single day, in approximately 30 minutes.
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of IOP. Coefficient of Variation will also be calculated).
OPA expressed in mmHg
Time frame: measurements will be taken in a single day, in approximately 30 minutes.
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of OPA. Coefficient of Variation will also be calculated).
2 secondary outcomes
IOP difference (expressed in mmHG) between first GAT and DCT
Time frame: partecipants will undergo a GAT diurnal tonometric curve (one day duration) and after one to seven days will undergo 5 DCT (approx. duration 30 minutes)
IOP difference (expressed in mmHG) between DCT and last GAT
Time frame: partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes)
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 27 Nov 2012.
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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.
Luigi Varano, M. D. principal investigator
University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DCT (PASCAL© Tonometer) IOP and OPA measurement in people with Intraocular Pressure and Central Corneal Thickness, run by University of Catanzaro at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 27 Nov 2012. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IOP expressed in mmHg (time frame: measurements will be taken in a single day, in approximately 30 minutes.). 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 27 Nov 2012.