SENSIMED Triggerfish® in Sitting and Supine Position
Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.
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 Apr 2011
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
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 17, 2012
April 1, 2012
11 months
May 2, 2011
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence
45 minutes
Secondary Outcomes (3)
Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine
30 minutes
IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position
2 hours
Monitoring with study device obtained before Day 2
20 hours
Interventions
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
Eligibility Criteria
You may qualify if:
- Subject is able to provide informed consent
- Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism
- No more than 4 diopters spherical equivalent
- No more than 2 diopters cylinder equivalent
- GAT IOP difference between eyes within 1 mmHg during initial exam
- GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam
- ≥ 18 years
- For women with childbearing potential, adequate contraception
You may not qualify if:
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- History of eye surgery
- Full frame metal glasses during SENSIMED Triggerfish® recording
- Known hypersensitivity to silicone, plaster or ocular anesthesia
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sensimed AGlead
Study Sites (1)
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaniv Barkana, MD
Assaf-Harofeh Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 4, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
April 17, 2012
Record last verified: 2012-04