Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Sensimed Triggerfish Sensor
* Device: Goldmann Applanation Tonometry, Perkins Tonometry


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensimed Triggerfish<br> | Device: Sensimed Triggerfish Sensor<br>* IOP will be monitored for 24 hours<br>|
| Active Comparator: Goldmann Applanation Tonometry/Perkins Tonometry<br> | Device: Goldmann Applanation Tonometry, Perkins Tonometry<br>* IOP will be measured every two hours within 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Correlation of IOP profile (TF) right versus left eye | Correlation of TF data right and left eye (mean, min, max, fluctuation) | 48 hours | 
| 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 | 
| Correlation of IOP with heart rate | Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation) | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison