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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Placement of Sensimed Triggerfish

• Registration Number: NCT04000828
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-22
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

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

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• in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single Arm	Placement of Sensimed Triggerfish	all patients receive the measurement with Sensimed Triggerfish

Primary Outcome Measures

Name	Time	Method
Amplitude	up to 14 weeks	Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy

Secondary Outcome Measures

Name	Time	Method
Correlation of other parameters	up to 14 weeks	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

Trial Locations

Locations (1)

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Germany