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SENSIMED Triggerfish® in Sitting and Supine Position

This study has been completed.
Sponsor:
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01347229
First received: May 2, 2011
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Healthy Subjects
 Device: SENSIMED Triggerfish®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Monitoring with study device obtained before Day 2 [ Time Frame: 20 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SENSIMED Triggerfish®
    Soft contact lens-based device for the continuous monitoring of IOP fluctuations
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347229

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

No publications provided

Responsible Party: Jeam-Marc Wismer, Sensimed AG
ClinicalTrials.gov Identifier: NCT01347229     History of Changes
Other Study ID Numbers: 10/06
Study First Received: May 2, 2011
Last Updated: April 16, 2012
Health Authority: Switzerland: Swiss Agency for Therapeutic Products

Keywords provided by Sensimed AG:
Glaucoma
Triggerfish
body position

ClinicalTrials.gov processed this record on June 18, 2013