Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
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|ClinicalTrials.gov Identifier: NCT01769521|
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma Normal Tension Glaucoma||Device: Sensimed Triggerfish®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Prospective, Open Label Study Assessing the Relationship Between the 24-hour Intraocular Pressure Pattern as Determined by Sensimed Triggerfish® and the 24-hour Blood Pressure Pattern in Patients With Primary Open Angle Glaucoma|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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 [ Time Frame: 24-hour ]The nycthemeral IOP fluctuation pattern, will be derived from the Triggerfish®, over a 24-hour period. Curves will be plotted for the IOP fluctuation.
- Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours) [ Time Frame: 24 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.
- Relationship between intraocular pulsation amplitude and BP [ Time Frame: 24-hours ]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.
- Relationship between the intraocular pulsation frequency and heart rate (HR) [ Time Frame: 24-hours ]The relationship between the intraocular pulsation frequency as determined by Triggerfish® will be correlated with the heart frequency as determined by ECG
- Assess safety and tolerability [ Time Frame: 24-hours ]AEs and SAEs will be collected throughout the duration of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769521
|Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski|
|Poznan, Poland, 61-848|
|Principal Investigator:||Jarosław Kocięcki, MD||Przemienienia Pańskiego Hospital|