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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Glaucoma

Treatments: Device: Placement of Sensimed Triggerfish

Study type: Interventional

Funder types: Other

Identifiers

NCT04000828

2019-14131

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

single Arm

Other group

Description:

all patients receive the measurement with Sensimed Triggerfish

Treatment:

Device: Placement of Sensimed Triggerfish