Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Katrin Lorenz

Status: Completed

Conditions: Primary Open Angle Glaucoma

Treatments: Device: Goldmann Applanation Tonometry, Perkins Tonometry; Device: Sensimed Triggerfish Sensor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01391078

Sensimed Triggerfish11/01

Details and patient eligibility

About

This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)
• Similar behaviour of IOP in both eyes in former IOP profiles
• 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
• For women with childbearing potential, adequate contraception

Exclusion Criteria:

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Sensimed Triggerfish

Experimental group

Treatment:

Device: Sensimed Triggerfish Sensor

Goldmann Applanation Tonometry/Perkins Tonometry

Active Comparator group

Treatment:

Device: Goldmann Applanation Tonometry, Perkins Tonometry