NCT01541501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

First QC Date

February 20, 2012

Last Update Submit

September 2, 2012

Conditions

Keywords

Central Corneal ThicknessPachymetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Pachymetry

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

Device: Pachymetry

Interventions

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.

Also known as: 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).
Pachymetry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catanzaro - Eye Department

Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Interventions

Corneal Pachymetry

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Luigi Varano, M. D.

    University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Varano, M. D.

CONTACT

Giovanni Scorcia, M. D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. D.

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 1, 2012

Study Start

September 1, 2011

Study Completion

December 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations