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Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

This study has been completed.
Sponsor:
Collaborator:
Sensimed AG
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01391078
First received: June 14, 2011
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Primary Open Angle Glaucoma
 Device: Sensimed Triggerfish Sensor
Device: Goldmann Applanation Tonometry, Perkins Tonometry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Relation of GAT/Perkins with TF in a cross-over regression analysis. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)

  • Correlation of IOP profile (GAT) right versus left eye [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)

  • Correlation of IOP profile (TF) right versus left eye [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Correlation of TF data right and left eye (mean, min, max, fluctuation)

  • Correlation of IOP with blood pressure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)

  • Correlation of IOP with heart rate [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)


Enrollment: 12
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391078

Locations
Germany
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz
Mainz, RLP, Germany, 55131
Sponsors and Collaborators
Katrin Lorenz
Sensimed AG
  More Information

No publications provided

Responsible Party: Katrin Lorenz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01391078     History of Changes
Other Study ID Numbers: Sensimed Triggerfish11/01
Study First Received: June 14, 2011
Last Updated: November 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
glaucoma
IOP
Sensimed Triggerfish
 Goldmann Applanation Tonometry
fluctuation
comparison

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013