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

Sponsor

Sensimed AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01769521

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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®	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Oct 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Nycthemeral IOP pattern [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) [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 [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) [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 [24-hours]
AEs and SAEs will be collected throughout the duration of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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