Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Normal Tension Glaucoma
• Intervention / Treatment: Device: Sensimed Triggerfish®

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 61-848
    • Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of POAG, including progressing normal tension glaucoma (NTG) based on recent or recurrent disc haemorrhage
• No anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to SD0 and absent throughout the study
• Aged more than 18 years, of either sex
• Not more than 4 diopters spherical equivalent on both eyes
• Not more than 2 diopters cylinder equivalent on both eyes
• Have given written informed consent, prior to pre-study screening

Exclusion Criteria:

• Patients with history of ocular surgery within the last 3 months
• Corneal or conjunctival abnormality hindering contact lens adaptation
• Severe dry eye
• Secondary forms of OAG
• Patients with systemic hypertension
• Patients with allergy to corneal anesthetic
• Patients with contraindications for silicone contact lens wear
• Wear of full frame metallic glasses during Triggerfish® monitoring
• Patients not able to understand the character and individual consequences of the investigation
• Simultaneous participation in other clinical research

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Triggerfish; Device: Sensimed Triggerfish	Device: Sensimed Triggerfish®; Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24-hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	24-hours
Assess safety and tolerability	AEs and SAEs will be collected throughout the duration of the study	24-hours

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: Jarosław Kocięcki, MD, Przemienienia Pańskiego Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (ESTIMATE): January 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Blood pressure; Glaucoma; IOP; ECG
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
• Other Study ID Numbers: TF-1011