Reliability of Dynamic Contour Tonometry (DCT) (DCT)

November 25, 2012 updated by: Luigi Varano, MD - Principal Investigator, University of Catanzaro

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • University of Catanzaro - Eye Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dynamic Contour Tonometry
All recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements.
Device: DCT (PASCAL© Tonometer) IOP and OPA measurement

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.

Other Names:
  • Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).
  • Goldmann Applanation Tonometry (AT900© - Haag-Streit AG, Koeniz, Switzerland)
  • Dynamic Contour Tonometry (PASCAL© Tonometer - Ziemer Ophthalmic Systems AG, Port, Switzerland)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
measurements will be taken in a single day, in approximately 30 minutes.
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).
measurements will be taken in a single day, in approximately 30 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)

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.
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)
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.
partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Catanzaro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luigi Varano, M. D., University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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