Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 28, 2012
November 1, 2012
7 months
June 14, 2011
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relation of GAT/Perkins with TF in a cross-over regression analysis.
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
48 hours
Secondary Outcomes (5)
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
Study Arms (2)
Sensimed Triggerfish
EXPERIMENTALGoldmann Applanation Tonometry/Perkins Tonometry
ACTIVE COMPARATORInterventions
IOP will be measured every two hours within 24 hours
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Katrin Lorenzlead
- Sensimed AGcollaborator
Study Sites (1)
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz
Mainz, RLP, 55131, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 14, 2011
First Posted
July 11, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
February 1, 2012
Last Updated
November 28, 2012
Record last verified: 2012-11