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Reliability of Dynamic Contour Tonometry (DCT) (DCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579331
First Posted: April 17, 2012
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luigi Varano, MD - Principal Investigator, University of Cantanzaro
  Purpose
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.

Condition Intervention Phase
Intraocular Pressure Central Corneal Thickness Device: DCT (PASCAL© Tonometer) IOP and OPA measurement Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry

Further study details as provided by Luigi Varano, MD - Principal Investigator, University of Cantanzaro:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


  • 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.


Enrollment: 102
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 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).

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579331


Locations
Italy
University of Catanzaro - Eye Department
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro
Investigators
Principal Investigator: Luigi Varano, M. D. University of Catanzaro
  More Information

Responsible Party: Luigi Varano, MD - Principal Investigator, M. D., University of Cantanzaro
ClinicalTrials.gov Identifier: NCT01579331     History of Changes
Other Study ID Numbers: DCT01
First Submitted: April 15, 2012
First Posted: April 17, 2012
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Luigi Varano, MD - Principal Investigator, University of Cantanzaro:
IOP
Tonometry
Pascal
Goldmann
DCT
Dynamic Contour