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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SENSIMED Triggerfish

Intervention Type DEVICE

Contact lens-based device for continuous intraocular pressure monitoring

Interventions

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SENSIMED Triggerfish

Contact lens-based device for continuous intraocular pressure monitoring

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No