Clinical trial NCT01769521: Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Normal Tension Glaucoma
Keywords: Glaucoma
IOP
Blood pressure
ECG
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24-hour
Secondary outcomes:
measure: Nycthemeral IOP pattern
timeFrame: 24-hour
measure: Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)
timeFrame: 24 hours
measure: Relationship between intraocular pulsation amplitude and BP
timeFrame: 24-hours
measure: Relationship between the intraocular pulsation frequency and heart rate (HR)
timeFrame: 24-hours
measure: Assess safety and tolerability
timeFrame: 24-hours
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski
Study officials:
affiliation: Przemienienia Pańskiego Hospital
name: Jarosław Kocięcki, MD
role: PRINCIPAL_INVESTIGATOR
References: