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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01769521
First received: January 10, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention
Primary Open Angle Glaucoma
Normal Tension Glaucoma
Device: Sensimed Triggerfish®

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

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. [ Time Frame: 24-hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769521

Locations
Poland
Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski
Poznan, Poland, 61-848
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Jarosław Kocięcki, MD Przemienienia Pańskiego Hospital
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01769521     History of Changes
Other Study ID Numbers: TF-1011
Study First Received: January 10, 2013
Last Updated: July 16, 2013
Health Authority: Poland: The Central Register of Clinical Trials

Keywords provided by Sensimed AG:
Glaucoma
IOP
Blood pressure
ECG

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on August 27, 2014