Primary Open Angle Glaucoma, Healthy Subjects
Conditions
Brief summary
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: 1. The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements 2. 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.
Interventions
DEVICESENSIMED Triggerfish
Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SENSIMED Triggerfish Efficacy | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment from July 2011 to May 2012, from medical clinic and investigator's patient database.
Pre-assignment details
Regular sleep cycle in the week preceding the study.
Participants by arm
| Arm | Count |
|---|---|
| SENSIMED Triggerfish | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | SENSIMED Triggerfish |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
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.
Time frame: from 1 hour before sleep to 1 hour after sleep
Population: Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENSIMED Triggerfish | SENSIMED Triggerfish Efficacy | 56.9 mV/h | Standard Deviation 40.5 |
Primary
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%.
Time frame: in selected 30-second SENSIMED Triggerfish recording intervals during sleep
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SENSIMED Triggerfish | SENSIMED Triggerfish Efficacy | 86.5 % of accurate recording intervals |