Comparison of Three Different No-contact Pachymetries

Corneal Thickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01541501
• Other study ID #: PAK-NC
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2012
• Last updated: September 2, 2012
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: University of Cantanzaro
• Contact: Luigi Varano, M. D.
• Phone: +39 0961 3647365
• Email: luigi-varano[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Thickness

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Catanzaro - Eye Department	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No