Corneal ThicknessNCT01541501
Comparison of Three Different No-contact Pachymetries
An observational study of Corneal Thickness, run by University of Catanzaro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Thickness
- What is being tested?
- Pachymetry
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Catanzaro - Eye Department
Catanzaro, 88100
Luigi Varano, M. D., +3909613647365, luigi-varano@libero.it
Giovanni Scorcia, M. D., +3909613647135, scorcia@unicz.it
About this study
Official title: Phase 4 Study of Comparison Among 3 Different No-contact Instruments to Valuate Central Corneal Thickness
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.
Read the 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.
- Conditions
- Corneal Thickness
- Being tested
- Pachymetry
- Keywords
- Central Corneal Thickness, Pachymetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PachymetryDevice
Also called 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).
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.
| Study group | Role | What they receive |
|---|---|---|
| Pachymetry | All recruited volunteers in present study, that underwent pachymetry measurement with four different instruments Receives: Device: Pachymetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
to valuate test-retest reliability of each instrument
Measured: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startSep 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Varano, MD - Principal Investigator, University of Catanzaro
- Investigators
- Luigi Varano, M. D., Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541501
- Sponsor's protocol ID
- PAK-NC
- Status last verified
- Sep 2012
- First submitted
- 20 Feb 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Comparison Among 3 Different No-contact Instruments to Valuate Central Corneal Thickness
- ClinicalTrials.gov ID
- NCT01541501
- Acronym / sponsor ID
- PAK-NC
- Conditions
- Corneal Thickness
- Keywords
- Central Corneal Thickness, Pachymetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Sep 2011
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pachymetry | – | Device: PachymetryAll recruited volunteers in present study, that underwent pachymetry measurement with four different instruments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PachymetryAlso: 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).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. | Device | Pachymetry |
Primary outcome
Central Corneal Thickness (CCT) expressed in microns (μm)
Time frame: 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).
1 secondary outcome
Central Corneal Thickness (CCT) expressed in microns (μm)
Time frame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Varano, M. D. principal investigator
University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Thickness, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Varano, M. D. (+39 0961 3647365, luigi-varano@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Corneal Thickness (CCT) expressed in microns (μm) (time frame: partecipants will be followed for one day, i. e. until the CCT measurements with all instruments object of present study are taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.