Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
NCT ID: NCT04000828
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2019-05-22
2020-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single Arm
all patients receive the measurement with Sensimed Triggerfish
Placement of Sensimed Triggerfish
Sensimed Triggerfish is placed on the corneal surface
Interventions
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Placement of Sensimed Triggerfish
Sensimed Triggerfish is placed on the corneal surface
Eligibility Criteria
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Inclusion Criteria
* 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* in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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
* 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
18 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Katrin Lorenz
Head of clinical trial site
Locations
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Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Mainz, , Germany
Countries
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Other Identifiers
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2019-14131
Identifier Type: -
Identifier Source: org_study_id
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