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

NCT01769521 | Completed

• 1 other identifier: TF-1011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Normal Tension Glaucoma

Keywords

Glaucoma; IOP; Blood pressure; ECG

Outcome Measures

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.

  24-hour

Secondary Outcomes (5)

• Nycthemeral IOP pattern

  24-hour

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

  24 hours

• Relationship between intraocular pulsation amplitude and BP

  24-hours

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

  24-hours

• Assess safety and tolerability

  24-hours

Study Arms (1)

Triggerfish

EXPERIMENTAL

Device: Sensimed Triggerfish

Device: Sensimed Triggerfish®

Interventions

Sensimed Triggerfish® DEVICE

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

Triggerfish

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski

Poznan, 61-848, Poland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Jarosław Kocięcki, MD

  Przemienienia Pańskiego Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 16, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

PL (1)