Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
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.
Primary Open Angle Glaucoma
Normal Tension Glaucoma
Device: Sensimed Triggerfish®
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: No ]
- Nycthemeral IOP pattern [ Time Frame: 24-hour ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]AEs and SAEs will be collected throughout the duration of the study
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Device: Sensimed Triggerfish
Device: Sensimed Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
|Contact: Jarosław Kocięcki, MD||+48 60 firstname.lastname@example.org|
|Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski||Recruiting|
|Poznan, Poland, 61-848|
|Contact: Ewa Czaplicka, MD +48 60 8549284 email@example.com|
|Contact: Robert Wasilewicz, MD +48 60 8549284 firstname.lastname@example.org|
|Sub-Investigator: Ewa Czaplicka, MD|
|Principal Investigator:||Jarosław Kocięcki, MD||Przemienienia Pańskiego Hospital|