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

Sensimed

Status: Completed

Conditions: Healthy Subjects; Primary Open Angle Glaucoma

Treatments: Device: SENSIMED Triggerfish

Study type: Interventional

Funder types: Industry

Identifiers

NCT01390779

10/09

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

SENSIMED Triggerfish

Experimental group

Description:

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.

Treatment:

Device: SENSIMED Triggerfish