Relationship Between 24-hour IOP Pattern and the 24-hour... | NCT01769521

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

NCT01769521

Sponsor

Sensimed AG

Status

Completed

Last Update Posted

Nov 17, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma
Normal Tension Glaucoma

Interventions

Sensimed Triggerfish®

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Jan 14, 2013

First Posted Date

Jan 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2015

Last Update Posted Date

Nov 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Triggerfish	Experimental	Device: Sensimed Triggerfish	Device: Sensimed Triggerfish®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sensimed Triggerfish®	Device	Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours	Triggerfish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jarosław Kocięcki, MD	Przemienienia Pańskiego Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski		Poznan		61-848	Poland

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D057066	Low Tension Glaucoma
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D009901	Optic Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided