Comparison of Three Different No-contact Pachymetries

• Conditions: Corneal Thickness
• Interventions: Device: Pachymetry

• Registration Number: NCT01541501
• Lead Sponsor: University of Catanzaro

Brief Summary

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-03-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-02
• Last Update Posted: 2012-09-05
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pachymetry	Pachymetry	All recruited volunteers in present study, that underwent pachymetry measurement with four different instruments

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness (CCT) expressed in microns (μm)	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

Name	Time	Method
Central Corneal Thickness (CCT) expressed in microns (μm)	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

Trial Locations

Locations (1)

University of Catanzaro - Eye Department; 🇮🇹 Catanzaro, Italy