MedDataX Logo

Reliability of Dynamic Contour Tonometry (DCT)

NCT ID: NCT01579331

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraocular Pressure Central Corneal Thickness

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

IOP Tonometry Pascal Goldmann DCT Dynamic Contour

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dynamic Contour Tonometry

All recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements.

Group Type EXPERIMENTAL

DCT (PASCAL© Tonometer) IOP and OPA measurement

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luigi Varano, MD - Principal Investigator

M. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luigi Varano, M. D.

Role: PRINCIPAL_INVESTIGATOR

University of Catanzaro

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Catanzaro - Eye Department

Catanzaro, Catanzaro, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCT01

Identifier Type: -

Identifier Source: org_study_id