Reliability of Dynamic Contour Tonometry (DCT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Pressure Central Corneal Thickness |
Device: DCT (PASCAL© Tonometer) IOP and OPA measurement |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry |
- IOP expressed in mmHg [ Time Frame: measurements will be taken in a single day, in approximately 30 minutes. ] [ Designated as safety issue: No ]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).
- OPA expressed in mmHg [ Time Frame: measurements will be taken in a single day, in approximately 30 minutes. ] [ Designated as safety issue: No ]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).
- IOP difference (expressed in mmHG) between first GAT and DCT [ Time Frame: 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) ] [ Designated as safety issue: No ]
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.
- IOP difference (expressed in mmHG) between DCT and last GAT [ Time Frame: partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes) ] [ Designated as safety issue: No ]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.
| Enrollment: | 102 |
| Study Start Date: | July 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dynamic Contour Tonometry
All recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements.
|
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. Other Names:
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Luigi Varano, MD - Principal Investigator, M. D., University of Cantanzaro |
| ClinicalTrials.gov Identifier: | NCT01579331 History of Changes |
| Other Study ID Numbers: | DCT01 |
| Study First Received: | April 15, 2012 |
| Last Updated: | November 25, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Cantanzaro:
|
IOP Tonometry Pascal |
Goldmann DCT Dynamic Contour |
ClinicalTrials.gov processed this record on May 19, 2013