24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry
Completed
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Device: SENSIMED Triggerfish
- Registration Number
- NCT01217853
- Lead Sponsor
- Sensimed AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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- Absence of or withdrawn informed consent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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SENSIMED Triggerfish SENSIMED Triggerfish -
- Primary Outcome Measures
Name Time Method SENSIMED Triggerfish output values During 24 hours Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.
Goldmann applanation tonometry values During 24 hours Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Schlosspark-Klinik
🇩🇪Berlin, Germany
Johannes Gutenberg Universitätsklinik Mainz
🇩🇪Mainz, Germany