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Completed

NCT Number: NCT01579331

Reliability of Dynamic Contour Tonometry (DCT)

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.

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Key information

Conditions

Intraocular Pressure Central Corneal Thickness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Catanzaro - Eye Department

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DCT (PASCAL© Tonometer) IOP and OPA measurement

Device

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: Goldmann Applanation Tonometry (AT900© - Haag-Streit AG, Koeniz, Switzerland), Dynamic Contour Tonometry (PASCAL© Tonometer - Ziemer Ophthalmic Systems AG, Port, Switzerland), Ultrasound pachymeter (Pacline© - Optikon ind., Rome, Italy).

Primary outcomes

  1. IOP expressed in mmHg

    Time frame: 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).

  2. OPA expressed in mmHg

    Time frame: 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 outcomes

  1. 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)

    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.

  2. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Acronym: DCT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2012
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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