Comparison of Three Different No-contact Pachymetries

NCT ID: NCT01541501

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Corneal Thickness

Keywords

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Central Corneal Thickness Pachymetry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pachymetry

All recruited volunteers in present study, that underwent pachymetry measurement with four different instruments

Pachymetry

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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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).

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luigi Varano, MD - Principal Investigator

M. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luigi Varano, M. D.

Role: PRINCIPAL_INVESTIGATOR

University of Catanzaro

Locations

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University of Catanzaro - Eye Department

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luigi Varano, M. D.

Role: CONTACT

Phone: +39 0961 3647365

Email: [email protected]

Giovanni Scorcia, M. D.

Role: CONTACT

Phone: +39 0961 3647135

Email: [email protected]

Facility Contacts

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Luigi Varano, M. D.

Role: primary

Giovanni Scorcia, M. D.

Role: backup

Other Identifiers

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PAK-NC

Identifier Type: -

Identifier Source: org_study_id