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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769521
• Other study ID #: TF-1011
• Status: Completed
• Phase: N/A
• First received: January 10, 2013
• Last updated: November 16, 2015
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Low Tension Glaucoma
• Normal Tension Glaucoma
• Primary Open Angle Glaucoma

Intervention

Device:
• Sensimed Triggerfish®
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Locations

Country	Name	City	State
Poland	Przemienienia Panskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assess safety and tolerability	AEs and SAEs will be collected throughout the duration of the study	24-hours	Yes