Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391078
• Other study ID #: Sensimed Triggerfish11/01
• Status: Completed
• Phase: N/A
• First received: June 14, 2011
• Last updated: November 27, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• Sensimed Triggerfish Sensor
IOP will be monitored for 24 hours
• Goldmann Applanation Tonometry, Perkins Tonometry
IOP will be measured every two hours within 24 hours

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz	Mainz	RLP

Sponsors (2)

Lead Sponsor	Collaborator
Katrin Lorenz	Sensimed AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation of GAT/Perkins with TF in a cross-over regression analysis.	Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)	48 hours	No
Secondary	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)	48 hours	No
Secondary	Correlation of IOP profile (GAT) right versus left eye	Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)	48 hours	No
Secondary	Correlation of IOP profile (TF) right versus left eye	Correlation of TF data right and left eye (mean, min, max, fluctuation)	48 hours	No
Secondary	Correlation of IOP with blood pressure	Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)	48 hours	No
Secondary	Correlation of IOP with heart rate	Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)	48 hours	No