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OpenTrials
Completed

NCT Number: NCT04000828

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Treatment and study plan

Placement of Sensimed Triggerfish

Device

Sensimed Triggerfish is placed on the corneal surface

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2019
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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