Reliability of Dynamic Contour Tonometry (DCT)

Intraocular Pressure Clinical Trial

— DCT  

Official title:

Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579331
• Other study ID #: DCT01
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2012
• Last updated: November 25, 2012
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Central Corneal Thickness
• Intraocular Pressure

Intervention

Device:
• DCT (PASCAL© Tonometer) IOP and OPA measurement
Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will undergo a series of 5 Dynamic contour tonometries to evaluate eventual differences among measurements. Patients will be controlled for 30 days. 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.

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	IOP expressed in mmHg	5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of IOP. Coefficient of Variation will also be calculated).	measurements will be taken in a single day, in approximately 30 minutes.	No
Primary	OPA expressed in mmHg	5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of OPA. Coefficient of Variation will also be calculated).	measurements will be taken in a single day, in approximately 30 minutes.	No
Secondary	IOP difference (expressed in mmHG) between first GAT and DCT	The diurnal tonometric curve (i.e. IOP at 9am, noon, 4pm) will be measured using GAT.; After 1 to 7 days, 5 different IOP measurements recorded every 2 minutes (+/- 1) will be measured at 9am (+/- 15 minutes) using DCT. The difference between GAT and DCT values will be calculated.	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)	No
Secondary	IOP difference (expressed in mmHG) between DCT and last GAT	5 different IOP measurements recorded every 2 minutes (+/- 1) will be measured at 9am (+/- 15 minutes) using DCT. After 1-2 minutes a single GAT measurement will be recorded. The difference between GAT and DCT values will be calculated.	partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes)	No