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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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ClinicalTrials.gov Identifier: NCT04000828
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Katrin Lorenz, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment Phase
Glaucoma Device: Placement of Sensimed Triggerfish Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Amplitude [ Time Frame: 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 [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000828


Contacts
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Contact: Katrin Lorenz, PD Dr. Dr. 00496131/174069 katrin.lorenz@unimedizin-mainz.de
Contact: Anna Beck, Dr. 00496131/177508 anna.beck@unimedizin-mainz.de

Locations
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Germany
Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz Recruiting
Mainz, Germany, 55131
Contact: Katrin Lorenz, MD    0049 6131 17 ext 4069    katrin.lorenz@unimedizin-mainz.de   
Contact: Anna Beck, MD    0049 6131 17 ext 7508    anna.beck@unimedizin-mainz.de   
Principal Investigator: Katrin Lorenz, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz

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Responsible Party: Katrin Lorenz, Head of clinical trial site, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04000828     History of Changes
Other Study ID Numbers: 2019-14131
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases