Status:
COMPLETED
24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry
Lead Sponsor:
Sensimed AG
Collaborating Sponsors:
Schlossparkklinik
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
40-70 years
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...
Eligibility Criteria
Inclusion
- 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
- 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- Absence of or withdrawn informed consent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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01217853
Start Date
August 1 2010
End Date
August 1 2011
Last Update
August 3 2011
Active Locations (2)
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1
Schlosspark-Klinik
Berlin, Germany, 14059
2
Johannes Gutenberg Universitätsklinik Mainz
Mainz, Germany, 55131