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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SENSIMED Triggerfish	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.

Primary Outcome Measures

Name	Time	Method
SENSIMED Triggerfish Efficacy	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%.

Secondary Outcome Measures