Clinical trial NCT01541501: Comparison of Three Different No-contact Pachymetries
Official title: Phase 4 Study of Comparison Among 3 Different No-contact Instruments to Valuate Central Corneal Thickness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Thickness
Keywords: Central Corneal Thickness
Pachymetry
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: Central Corneal Thickness (CCT) expressed in microns (μm)
timeFrame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken
Secondary outcomes:
measure: Central Corneal Thickness (CCT) expressed in microns (μm)
timeFrame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University of Catanzaro - Eye Department
Study officials:
affiliation: University of Catanzaro
name: Luigi Varano, M. D.
role: PRINCIPAL_INVESTIGATOR
References: