SENSIMED Triggerfish® in Sitting and Supine Position

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347229
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : April 17, 2012
Information provided by:
Sensimed AG

Brief Summary:
The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: SENSIMED Triggerfish® Not Applicable

Detailed Description:
20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers
Study Start Date : April 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Intervention Details:
    Device: SENSIMED Triggerfish®
    Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Primary Outcome Measures :
  1. Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence [ Time Frame: 45 minutes ]

Secondary Outcome Measures :
  1. Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine [ Time Frame: 30 minutes ]
  2. IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position [ Time Frame: 2 hours ]
  3. Monitoring with study device obtained before Day 2 [ Time Frame: 20 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject is able to provide informed consent
  • Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism
  • No more than 4 diopters spherical equivalent
  • No more than 2 diopters cylinder equivalent
  • GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP > 21 mmHg
  • GAT IOP difference between eyes within 1 mmHg during initial exam
  • GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam
  • ≥ 18 years
  • For women with childbearing potential, adequate contraception

Exclusion Criteria:

  • Subjects with contraindications for wearing contact lenses
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormality
  • Conjunctival or intraocular inflammation
  • History of eye surgery
  • Full frame metal glasses during SENSIMED Triggerfish® recording
  • Known hypersensitivity to silicone, plaster or ocular anesthesia
  • Pregnancy and lactation
  • Simultaneous participation in other clinical studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347229

Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Sensimed AG
Principal Investigator: Yaniv Barkana, MD Assaf-Harofeh Medical Center

Responsible Party: Jeam-Marc Wismer, Sensimed AG Identifier: NCT01347229     History of Changes
Other Study ID Numbers: 10/06
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Sensimed AG:
body position