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Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sensimed Triggerfish Sensor
Goldmann Applanation Tonometry, Perkins Tonometry
Sponsored by
Katrin Lorenz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Open Angle Glaucoma focused on measuring glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensimed Triggerfish

Goldmann Applanation Tonometry/Perkins Tonometry

Arm Description

Outcomes

Primary Outcome Measures

Relation of GAT/Perkins with TF in a cross-over regression analysis.
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)
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Correlation of IOP profile (GAT) right versus left eye
Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)
Correlation of IOP profile (TF) right versus left eye
Correlation of TF data right and left eye (mean, min, max, fluctuation)
Correlation of IOP with blood pressure
Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)
Correlation of IOP with heart rate
Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)

Full Information

First Posted
June 14, 2011
Last Updated
November 27, 2012
Sponsor
Katrin Lorenz
Collaborators
Sensimed AG
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1. Study Identification

Unique Protocol Identification Number
NCT01391078
Brief Title
Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry
Official Title
Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katrin Lorenz
Collaborators
Sensimed AG

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensimed Triggerfish
Arm Type
Experimental
Arm Title
Goldmann Applanation Tonometry/Perkins Tonometry
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Sensimed Triggerfish Sensor
Intervention Description
IOP will be monitored for 24 hours
Intervention Type
Device
Intervention Name(s)
Goldmann Applanation Tonometry, Perkins Tonometry
Intervention Description
IOP will be measured every two hours within 24 hours
Primary Outcome Measure Information:
Title
Relation of GAT/Perkins with TF in a cross-over regression analysis.
Description
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)
Description
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Time Frame
48 hours
Title
Correlation of IOP profile (GAT) right versus left eye
Description
Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)
Time Frame
48 hours
Title
Correlation of IOP profile (TF) right versus left eye
Description
Correlation of TF data right and left eye (mean, min, max, fluctuation)
Time Frame
48 hours
Title
Correlation of IOP with blood pressure
Description
Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)
Time Frame
48 hours
Title
Correlation of IOP with heart rate
Description
Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Facility Information:
Facility Name
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz
City
Mainz
State/Province
RLP
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

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Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

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