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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000828
• Other study ID #: 2019-14131
• Status: Completed
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: April 14, 2020

Study information

• Verified date: August 2021
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Placement of Sensimed Triggerfish
Sensimed Triggerfish is placed on the corneal surface

Locations

Country	Name	City	State
Germany	Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude	Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy	up to 14 weeks
Secondary	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