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Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

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ClinicalTrials.gov Identifier: NCT01391078
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : November 28, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Primary Open Angle Glaucoma Device: Sensimed Triggerfish Sensor Device: Goldmann Applanation Tonometry, Perkins Tonometry

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : January 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Katrin Lorenz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01391078     History of Changes
Other Study ID Numbers: Sensimed Triggerfish11/01
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Katrin Lorenz, 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