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Comparison of Three Different No-contact Pachymetries

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Luigi Varano, MD - Principal Investigator, University of Cantanzaro.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541501
First Posted: March 1, 2012
Last Update Posted: September 5, 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 compare central corneal thickness (CCT) obtained through 3 different no-contact instruments and to compare them with contact ultrasound pachymetry, actually the gold standard technique.

Condition Intervention
Corneal Thickness Device: Pachymetry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study of Comparison Among 3 Different No-contact Instruments to Valuate Central Corneal Thickness

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

Primary Outcome Measures:
  • Central Corneal Thickness (CCT) expressed in microns (μm) [ Time Frame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken ]
    to valuate differences among all obtained no-contact CCT measurements and compare them with the CCT measured with the reference tool (Ultrasound pachymeter).


Secondary Outcome Measures:
  • Central Corneal Thickness (CCT) expressed in microns (μm) [ Time Frame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken ]
    to valuate test-retest reliability of each instrument


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Groups/Cohorts Assigned Interventions
Pachymetry
All recruited volunteers in present study, that underwent pachymetry measurement with four different instruments
Device: Pachymetry
Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will be submitted to CCT measurement through four different instruments: Scheimpflug camera tomography, SD-OCT, anterior chamber SD-OCT, and finally with US pachymeter.
Other Names:
  • Scheimpflug camera tomography (Pentacam© HR - Oculus ind., Wetzlar, Germany).
  • SD-OCT (RTVue© - Optovue inc. Fremont, CA, USA).
  • anterior chamber SD-OCT (CASIA©, Tomey corp., Nagoya, Japan).
  • Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).

Detailed Description:

Corneal pachymetry is the measurement of corneal thickness, usually expressed in microns (μ).

Pachymetry is systematically used for the monitoring of corneal oedema, for the management and assessment of the progression risk of the ocular hypertension, for the diagnosis, the management and follow-up of keratoconus, as well as it is important in the pre and postoperative management of corneal surgical procedures. CCT is a factor well known to influence tonometry. Its assessment is fundamental in glaucoma practice to allow a correct intraocular pressure (IOP) evaluation.

The purpose of this study is to compare CCT measurements using four different instruments: Scheimpflug camera tomography, spectral-domain optical coherence tomography (SD-OCT), anterior chamber SD-OCT and ultrasound pachymetry.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic
Criteria

Inclusion Criteria:

  • subjects that gave a valid consensus to be included in this experimentation,
  • aged between 18 and 75 years,
  • Best-Corrected Visual Acuity (BCVA) of 20/100 or better,
  • refraction included between -6 and +6 dioptres,
  • astigmatism included between -2 and +2 dioptres.

Exclusion Criteria:

  • History of refractive surgery or any keratoplasty procedure,
  • corneal opacities or diseases that make not suitable applanation tonometry or pachymetry.
  • Use of contact lenses.
  • History of corneal dystrophies or degenerative diseases, (like keratoconus and pellucid marginal degeneration).
  • History of glaucoma or ocular hypertension.
  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): NCT01541501


Contacts
Contact: Luigi Varano, M. D. +39 0961 3647365 luigi-varano@libero.it
Contact: Giovanni Scorcia, M. D. +39 0961 3647135 scorcia@unicz.it

Locations
Italy
University of Catanzaro - Eye Department Recruiting
Catanzaro, Italy, 88100
Contact: Luigi Varano, M. D.    +3909613647365    luigi-varano@libero.it   
Contact: Giovanni Scorcia, M. D.    +3909613647135    scorcia@unicz.it   
Principal Investigator: Luigi Varano, M. D.         
Sub-Investigator: Claudia Persico, M. D.         
Sub-Investigator: Andrea Muraca, M. D.         
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: NCT01541501     History of Changes
Other Study ID Numbers: PAK-NC
First Submitted: February 20, 2012
First Posted: March 1, 2012
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Luigi Varano, MD - Principal Investigator, University of Cantanzaro:
Central Corneal Thickness
Pachymetry