Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy

Study Overview
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Brief Summary
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A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy

Official Title
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Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Placement of Sensimed Triggerfish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have the willingness and ability to provide signed informed consent Patient is able to comply with the study procedure Patient must be ≥ 18 years old Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye planned trabeculectomy in the study eye in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile Patient has consented to be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 Exclusion Criteria: Subjects with contraindications for wearing contact lenses in the study eye secondary glaucoma in the study eye History of refractive surgery in the study eye History of intraocular surgery in the last three months in the study eye Severe dry eye syndrome as judged by the investigator in the study eye Keratoconus or other corneal abnormalities Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision Conjunctival or intraocular inflammation in the study eye Simultaneous participation in other clinical trials Previous IOP-lowering intervention in the study eye Current shift workers (applicable for at least 3 months) Transmeridian flight < 2 months before screening (6 hours time shift) Subjects with pacemaker

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single Arm<br>all patients receive the measurement with Sensimed Triggerfish | Device: Placement of Sensimed Triggerfish<br>* Sensimed Triggerfish is placed on the corneal surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude | Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy | up to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of other parameters | Correlation of IOP and Triggerfish Profile, Correlation of IOP, blood pressure and heart rate, Evaluation of 24 hours nyctohemeral rhythm of measurements before and after trabeculectomy | up to 14 weeks |