Comparison of Three Different No-contact Pachymetries

Phase 4 Study of Comparison Among 3 Different No-contact Instruments to Valuate Central Corneal Thickness

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Thickness
• Intervention / Treatment: Device: Pachymetry

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Luigi Varano, M. D.; Phone Number: +39 0961 3647365; Email: luigi-varano@libero.it
• Study Contact Backup: Name: Giovanni Scorcia, M. D.; Phone Number: +39 0961 3647135; Email: scorcia@unicz.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • University of Catanzaro - Eye Department
    • Contact: Luigi Varano, M. D.; Phone Number: +3909613647365; Email: luigi-varano@libero.it
    • Contact: Giovanni Scorcia, M. D.; Phone Number: +3909613647135; Email: scorcia@unicz.it
    • Principal Investigator: Luigi Varano, M. D.
    • Sub-Investigator: Claudia Persico, M. D.
    • Sub-Investigator: Andrea Muraca, M. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Investigators: Principal Investigator: Luigi Varano, M. D., University of Catanzaro

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 2, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Central Corneal Thickness; Pachymetry
• Other Study ID Numbers: PAK-NC