Comparison of Three Different No-contact Pachymetries

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Cantanzaro
Sponsor:
Information provided by (Responsible Party):
Luigi Varano, MD - Principal Investigator, University of Cantanzaro
ClinicalTrials.gov Identifier:
NCT01541501
First received: February 20, 2012
Last updated: September 2, 2012
Last verified: September 2012
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 20, 2012
Last Updated: September 2, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Cantanzaro:
Central Corneal Thickness
Pachymetry

ClinicalTrials.gov processed this record on July 20, 2014