Comparison of Sensimed Triggerfish (TF) 24 Hour Monitorin... | NCT04000828

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

NCT04000828

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

Sep 1, 2021Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Placement of Sensimed Triggerfish

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2019Actual

Primary Completion Date

Apr 14, 2020Actual

Completion Date

Apr 14, 2020Actual

First Submitted Date

May 27, 2019

First Submission Date that Met QC Criteria

Jun 26, 2019

First Posted Date

Jun 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single Arm	Other	all patients receive the measurement with Sensimed Triggerfish	Device: Placement of Sensimed Triggerfish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of Sensimed Triggerfish	Device	Sensimed Triggerfish is placed on the corneal surface	single Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases