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

Primary Open Angle Glaucoma Clinical Trial

Official title:

Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217853
• Other study ID #: 09/10
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: August 2, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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• Absence of or withdrawn informed consent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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• SENSIMED Triggerfish
Contact lens-based device for continuous intraocular pressure monitoring

Locations

Country	Name	City	State
Germany	Schlosspark-Klinik	Berlin
Germany	Johannes Gutenberg Universitätsklinik Mainz	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Sensimed AG	Schlossparkklinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SENSIMED Triggerfish output values	Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.	During 24 hours	No
Primary	Goldmann applanation tonometry values	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.	During 24 hours	No