NCT01579331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

April 15, 2012

Last Update Submit

November 25, 2012

Conditions

Intraocular PressureCentral Corneal Thickness

Keywords

IOPTonometryPascalGoldmannDCTDynamic Contour

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Secondary Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

Dynamic Contour Tonometry

EXPERIMENTAL

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

Interventions

DCT (PASCAL© Tonometer) IOP and OPA measurementDEVICE

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.

Also known as: 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).
Dynamic Contour Tonometry

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catanzaro - Eye Department

Catanzaro, Catanzaro, 88100, Italy

Location

Study Officials

  • Luigi Varano, M. D.

    University of Catanzaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. D.

Study Record Dates

First Submitted

April 15, 2012

First Posted

April 17, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

IT(1)