MedDataX Logo

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

NCT ID: NCT01769521

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Open Angle Glaucoma Normal Tension Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triggerfish

Device: Sensimed Triggerfish

Group Type EXPERIMENTAL

Sensimed Triggerfish®

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sensimed Triggerfish®

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jarosław Kocięcki, MD

Role: PRINCIPAL_INVESTIGATOR

Przemienienia Pańskiego Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Przemienienia Pańskiego Hospital, Poznan University of Medical Sciences Karol Marcinkowski

Poznan, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TF-1011

Identifier Type: -

Identifier Source: org_study_id