Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: Sensimed Triggerfish Sensor; Device: Goldmann Applanation Tonometry, Perkins Tonometry

• Registration Number: NCT01391078
• Lead Sponsor: Katrin Lorenz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sensimed Triggerfish	Sensimed Triggerfish Sensor	-
Goldmann Applanation Tonometry/Perkins Tonometry	Goldmann Applanation Tonometry, Perkins Tonometry	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, RLP, Germany