24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry

Sensimed

Status: Completed

Conditions: Primary Open Angle Glaucoma

Treatments: Device: SENSIMED Triggerfish

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01217853

09/10

Details and patient eligibility

About

A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent for the investigation
• Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
• Age 40-70 years at inclusion
• Not more than 4 diopters spherical equivalent on the study eye
• Not more than 2 diopters cylinder equivalent on the study eye
• For women of childbearing potential, adequate contraception
• Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation

Exclusion criteria

• Patients not able to understand the character and individual consequences of the investigation
• Patients committed to an institution by virtue of an order issued either by the courts or by an authority
• Absence of or withdrawn informed consent
• Patients with contraindications for silicone contact lens wear
• Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
• Eye disorders including severe dry eye
• Eye disorders secondary to POAG
• Patient who have had ocular surgery within the last 3 months
• Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
• Pregnancy and lactation
• Allergy to oxybuprocaine (ocular anesthesia)
• Simultaneous participation in other clinical research

Trial design

30 participants in 1 patient group

SENSIMED Triggerfish

Treatment:

Device: SENSIMED Triggerfish