Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391078

Enrollment

Registered

2011-07-11

Start date

2011-06-30

Completion date

2012-02-29

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma

Keywords

glaucoma, IOP, Sensimed Triggerfish, Goldmann Applanation Tonometry, fluctuation, comparison

Brief summary

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.

Interventions

DEVICESensimed Triggerfish Sensor

IOP will be monitored for 24 hours

DEVICEGoldmann Applanation Tonometry, Perkins Tonometry

IOP will be measured every two hours within 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Relation of GAT/Perkins with TF in a cross-over regression analysis.	48 hours	Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)

Secondary

Measure	Time frame	Description
Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)	48 hours	Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
Correlation of IOP profile (GAT) right versus left eye	48 hours	Correlation of GAT/Perkins values in the right and left eye (mean, min, max, fluctuation)
Correlation of IOP profile (TF) right versus left eye	48 hours	Correlation of TF data right and left eye (mean, min, max, fluctuation)
Correlation of IOP with blood pressure	48 hours	Correlation of GAT/Perkins values and TF data with systolic and diastolic blood pressure(mean, min, max, fluctuation)
Correlation of IOP with heart rate	48 hours	Correlation of GAT/Perkins values and TF data with pulse rate(mean, min, max, fluctuation)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026