Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
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|ClinicalTrials.gov Identifier: NCT01390779|
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : January 20, 2014
Last Update Posted : January 20, 2014
The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.
TF efficacy will be evaluated by demonstrating TF ability to detect:
- The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
- Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).
A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device recording.
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma Healthy Subjects||Device: SENSIMED Triggerfish||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: SENSIMED Triggerfish
All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.
Device: SENSIMED Triggerfish
Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours
- SENSIMED Triggerfish Efficacy [ Time Frame: from 1 hour before sleep to 1 hour after sleep ]
Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.
One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.
- SENSIMED Triggerfish Efficacy [ Time Frame: in selected 30-second SENSIMED Triggerfish recording intervals during sleep ]Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390779
|United States, California|
|San Diego, California, United States, 92093-0946|
|Principal Investigator:||John HK Liu, PhD||UCSD|