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

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Completed
CT.gov ID
NCT04000828
Collaborator
(none)
12
1
1
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Placement of Sensimed Triggerfish
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Actual Study Start Date :
May 22, 2019
Actual Primary Completion Date :
Apr 14, 2020
Actual Study Completion Date :
Apr 14, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Amplitude [up to 14 weeks]

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

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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  • in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz Mainz Germany 55131

Sponsors and Collaborators

  • Johannes Gutenberg University Mainz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katrin Lorenz, Head of clinical trial site, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT04000828
Other Study ID Numbers:
  • 2019-14131
First Posted:
Jun 27, 2019
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021