Central Corneal Thickness, Intraocular Pressure
Conditions
Keywords
IOP, Tonometry, Pascal, Goldmann, DCT, Dynamic Contour
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.
Interventions
DEVICEDCT (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.
Sponsors
University of Catanzaro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP expressed in mmHg | measurements will be taken in a single day, in approximately 30 minutes. | 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 | measurements will be taken in a single day, in approximately 30 minutes. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP difference (expressed in mmHG) between first GAT and DCT | 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) | 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 | partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes) | 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. |
Countries
Italy
Outcome results
None listed