Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients (BIOLENS)
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|ClinicalTrials.gov Identifier: NCT01849536|
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : November 25, 2013
Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP circadian rhythm is altered and varied widely between patients. To date, the only way to evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour hospitalization. This method is expensive and does not reflect physiological conditions because it requires IOP measurements during sleeping periods that may potentially produce artifacts.
Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. Then we will also analyze the influence of corneal parameters on continuous IOP fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma With a Progressive Visual Field||Device: SENSIMED Triggerfish®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: SENSIMED Triggerfish®
|Device: SENSIMED Triggerfish®|
- Corneal biomechanics influence on IOP fluctuation. [ Time Frame: 24h ]To evaluate corneal biomechanics influence on IOP fluctuation using SENSIMED Triggerfish® for glaucoma patients with a progressive visual field.
- Correlation between visual field defects and IOP fluctuations measurements. [ Time Frame: 24h ]To evaluate the correlation between visual field defects and IOP fluctuations measurements.
- Correlation between the severity of optic nerve head damages and IOP. fluctuations measurements [ Time Frame: 24h ]To evaluate the correlation between the severity of optic nerve head damages measured with OCT and IOP fluctuations measurements.
- Lens tolerance and corneal parameters after 24-hours of contact lens wear. [ Time Frame: 24h ]To evaluate lens tolerance and corneal parameters after 24-hours of contact lens wear (Pachymetry, Corneal hysteresis and Keratometry ).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849536
|Service d'ophtalmologie Hôpital Pellegrin|
|CHU de Bordeaux, Bordeaux, France, 33000|
|Principal Investigator:||Cédric SCHWEITZER, MD||University Hospital Bordeaux, France|