Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

Conditions
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Primary Open Angle Glaucoma, Healthy Subjects

Intervention / Treatment
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* Device: SENSIMED Triggerfish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent for the investigation Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists No anti-glaucomatous drug treatment or washed-out for 4 weeks IOP symmetry of +/- 3 mmHg between fellow eyes Age 18-80 years Not more than 4 diopters spherical equivalent on both eyes Not more than 2 diopters cylinder equivalent on both eyes Exclusion Criteria: Patients who have had ocular surgery within the last 3 months. Corneal or conjunctival abnormality hindering contact lens adaptation Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring Severe dry eye Secondary forms of open angle glaucoma (OAG) Allergy to corneal anesthetic Patients with contraindications for silicone contact lens wear Patients not able to understand the character and individual consequences of the investigation Simultaneous participation in other clinical research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SENSIMED Triggerfish<br>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<br>* Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENSIMED Triggerfish Efficacy | 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. | from 1 hour before sleep to 1 hour after sleep | 
| SENSIMED Triggerfish Efficacy | 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%. | in selected 30-second SENSIMED Triggerfish recording intervals during sleep |