An interventional study of Sensimed Triggerfish® in Primary Open Angle Glaucoma and Normal Tension Glaucoma, sponsored by Sensimed AG. Completed at 1 site in Poland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Sensimed AG · Not applicable and Interventional
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated.
The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
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This study's enrollment of 20 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Device: Sensimed Triggerfish
Device: Sensimed Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG.
Time frame: 24-hour
Nycthemeral IOP pattern
The nycthemeral IOP fluctuation pattern, will be derived from the Triggerfish®, over a 24-hour period. Curves will be plotted for the IOP fluctuation.
Time frame: 24-hour
Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)
The nocturnal IOP fluctuation pattern will be compared to that of the diurnal fluctuation pattern (office hours). The diurnal IOP fluctuation pattern will be compared to the tonometric IOP curve concomitantly assessed in the contralateral eye.
Time frame: 24 hours
Relationship between intraocular pulsation amplitude and BP
The relationship between intraocular pulsation amplitude and BP will be determined by the determination of the mean intraocular Triggerfish output (IOT), SIOT and DIOT and correlated to the mean BP, SBP and DBP.
Time frame: 24-hours
Relationship between the intraocular pulsation frequency and heart rate (HR)
The relationship between the intraocular pulsation frequency as determined by Triggerfish® will be correlated with the heart frequency as determined by ECG
Time frame: 24-hours
Assess safety and tolerability
AEs and SAEs will be collected throughout the duration of the study
Time frame: 24-hours
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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