Skip to main content
OpenTrials
Completed

NCT Number: NCT01391078

Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, RLP, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensimed Triggerfish Sensor

Device

IOP will be monitored for 24 hours

Goldmann Applanation Tonometry, Perkins Tonometry

Device

IOP will be measured every two hours within 24 hours

Primary outcomes

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

    Time frame: 48 hours

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

Secondary outcomes

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

    Time frame: 48 hours

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

  2. Correlation of IOP profile (GAT) right versus left eye

    Time frame: 48 hours

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

  3. Correlation of IOP profile (TF) right versus left eye

    Time frame: 48 hours

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

  4. Correlation of IOP with blood pressure

    Time frame: 48 hours

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

  5. Correlation of IOP with heart rate

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Katrin Lorenz

Other

Collaborators

  • Sensimed AG

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2011
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.