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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

May 2, 2011
April 16, 2012
April 2011
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01347229 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SENSIMED Triggerfish® in Sitting and Supine Position
Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy Subjects
Device: SENSIMED Triggerfish®
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01347229
10/06
No
Jeam-Marc Wismer, Sensimed AG
Sensimed AG
Not Provided
Principal Investigator: Yaniv Barkana, MD Assaf-Harofeh Medical Center
Sensimed AG
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP