Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Katrin Lorenz12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Primary Open Angle Glaucoma

Interventions

Sensimed Triggerfish SensorDEVICE

IOP will be monitored for 24 hours

Goldmann Applanation Tonometry, Perkins TonometryDEVICE

IOP will be measured every two hours within 24 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (1)

Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz

Mainz, RLP, Germany

Outcomes

Primary Outcomes

Relation of GAT/Perkins with TF in a cross-over regression analysis.

Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)

Time frame: 48 hours

Secondary Outcomes

Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)

Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)

Time frame: 48 hours

Correlation of IOP profile (GAT) right versus left eye

Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)

Time frame: 48 hours

Correlation of IOP profile (TF) right versus left eye

Correlation of TF data right and left eye (mean, min, max, fluctuation)

Time frame: 48 hours

Correlation of IOP with blood pressure

Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)

Time frame: 48 hours

Correlation of IOP with heart rate

Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)

Time frame: 48 hours

Data from ClinicalTrials.gov

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