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

August 31, 2021 updated by: Katrin Lorenz, Johannes Gutenberg University Mainz
A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: single Arm
all patients receive the measurement with Sensimed Triggerfish
Device: Placement of Sensimed Triggerfish
Sensimed Triggerfish is placed on the corneal surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude
Time Frame: up to 14 weeks
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
Time Frame: 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
up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2019

Primary Completion (ACTUAL)

April 14, 2020

Study Completion (ACTUAL)

April 14, 2020

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-14131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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