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

Sensimed

Status: Completed

Conditions: Primary Open Angle Glaucoma; Normal Tension Glaucoma

Treatments: Device: Sensimed Triggerfish®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01769521

TF-1011

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Triggerfish

Experimental group

Description:

Device: Sensimed Triggerfish

Treatment:

Device: Sensimed Triggerfish®