Skip to main content
OpenTrials
Completed

NCT Number: NCT01769521

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Low Tension Glaucoma Normal Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski

Poznan, 61-848, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish®

Device

Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Primary outcomes

  1. 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

Secondary outcomes

  1. Nycthemeral IOP pattern

    Time frame: 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.

  2. Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)

    Time frame: 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.

  3. Relationship between intraocular pulsation amplitude and BP

    Time frame: 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.

  4. Relationship between the intraocular pulsation frequency and heart rate (HR)

    Time frame: 24-hours

    The relationship between the intraocular pulsation frequency as determined by Triggerfish® will be correlated with the heart frequency as determined by ECG

  5. Assess safety and tolerability

    Time frame: 24-hours

    AEs and SAEs will be collected throughout the duration of the study

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2013
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.