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Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma

NCT01912599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-06-17

Study results available
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Summary

Purpose: To study the feasibility of a larger study by determining the tolerability of measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory fashion with automatic devices.

Participants: 20 patients with moderate to severe normal tension glaucoma and 20 non-glaucomatous patients.

Procedures (methods): Both BP and IOP will be measured automatically in each participant in an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person trained in ambulatory BP monitoring devices. The device will be set up to automatically inflate every 30 minutes during the day and every hour during the night to measure and record the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG, Lausanne, Switzerland); the measurements will be taken and recorded every 10 minutes. The contact lens will be inserted by eye doctors (investigators). Both monitoring devices will be removed the following day.

Conditions

  • Normal-Tension Glaucoma

Interventions

DEVICE

Sensimed Triggerfish

IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.

DEVICE

Blood Pressure

Patients in both groups will be fitted with a blood pressure cuff that will measure pressures for 24 hours.

Sponsors & Collaborators

  • Sensimed AG

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jean-Claude Mwanza, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912599 on ClinicalTrials.gov