Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

November 27, 2012 updated by: Katrin Lorenz

Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients

This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • RLP
      • Mainz, RLP, Germany, 55131
        • Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is able to comply with the study procedure
  • Patient must be ≥ 18 years old
  • Diagnosis of primary open angle glaucoma (EGS criteria)
  • Similar behaviour of IOP in both eyes in former IOP profiles
  • Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Visual Acuity of 20/200 or better in both eyes
  • Ability of subject to understand the character and individual consequences of the study
  • For women with childbearing potential, adequate contraception

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensimed Triggerfish
Device: Sensimed Triggerfish Sensor
IOP will be monitored for 24 hours
Active Comparator: Goldmann Applanation Tonometry/Perkins Tonometry
Device: Goldmann Applanation Tonometry, Perkins Tonometry
IOP will be measured every two hours within 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation of GAT/Perkins with TF in a cross-over regression analysis.
Time Frame: 48 hours
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)
Time Frame: 48 hours
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
48 hours
Correlation of IOP profile (GAT) right versus left eye
Time Frame: 48 hours
Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)
48 hours
Correlation of IOP profile (TF) right versus left eye
Time Frame: 48 hours
Correlation of TF data right and left eye (mean, min, max, fluctuation)
48 hours
Correlation of IOP with blood pressure
Time Frame: 48 hours
Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)
48 hours
Correlation of IOP with heart rate
Time Frame: 48 hours
Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katrin Lorenz

Collaborators

Sensimed AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sensimed Triggerfish11/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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