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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placement of Sensimed Triggerfish
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single Arm

Arm Description

all patients receive the measurement with Sensimed Triggerfish

Outcomes

Primary Outcome Measures

Amplitude
Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2019
Last Updated
August 31, 2021
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04000828
Brief Title
Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Official Title
Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single Arm
Arm Type
Other
Arm Description
all patients receive the measurement with Sensimed Triggerfish
Intervention Type
Device
Intervention Name(s)
Placement of Sensimed Triggerfish
Intervention Description
Sensimed Triggerfish is placed on the corneal surface
Primary Outcome Measure Information:
Title
Amplitude
Description
Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy
Time Frame
up to 14 weeks
Secondary Outcome Measure Information:
Title
Correlation of other parameters
Description
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
Time Frame
up to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

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

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