Clinical trial NCT01579331: Reliability of Dynamic Contour Tonometry (DCT)
Official title: Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Central Corneal Thickness
Keywords: IOP
Tonometry
Pascal
Goldmann
DCT
Dynamic Contour
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique.

Detailed description: Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate eventual differences among the measurements.

A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT.

At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.

After 3 weeks observers will contact patients to record eventual adverse events. If examiners consider it as necessary, a safety ophthalmological evaluation will then be performed.

Eligibility criteria: Inclusion Criteria:

* healthy subjects giving a valid consent to be included in this experimentation
* age between 18 and 80 years
* best corrected visual acuity (BCVA) of at least 20/100
* refraction ranging from -6 to +6 dioptres, with an astigmatism ranging from -2 to +2 dioptres

Exclusion Criteria:

* History of refractive surgery or any keratoplasty procedure.
* Corneal opacities or diseases making no suitable applanation tonometry.
* Use of contact lenses. History of glaucoma or ocular hypertension.
* History of diabetic retinopathy staged as severe non-proliferative or worse.

Primary outcomes:
measure: IOP expressed in mmHg
timeFrame: measurements will be taken in a single day, in approximately 30 minutes.
measure: OPA expressed in mmHg
timeFrame: measurements will be taken in a single day, in approximately 30 minutes.
Secondary outcomes:
measure: IOP difference (expressed in mmHG) between first GAT and DCT
timeFrame: partecipants will undergo a GAT diurnal tonometric curve (one day duration) and after one to seven days will undergo 5 DCT (approx. duration 30 minutes)
measure: IOP difference (expressed in mmHG) between DCT and last GAT
timeFrame: partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes)
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: