Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Katrin Lorenz
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Relation of GAT/Perkins with TF in a cross-over regression analysis.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Sensimed Triggerfish
Intervention: Sensimed Triggerfish Sensor (Device)
Goldmann Applanation Tonometry/Perkins Tonometry
Intervention: Goldmann Applanation Tonometry, Perkins Tonometry (Device)
Outcomes
Primary Outcomes
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
- 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 IOP profile (GAT) right versus left eye(48 hours)
- Correlation of IOP profile (TF) right versus left eye(48 hours)
- Correlation of IOP with blood pressure(48 hours)
- Correlation of IOP with heart rate(48 hours)
Investigators
Katrin Lorenz
MD
Johannes Gutenberg University Mainz