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Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Measurement Device Sensimed Triggerfish Intraocular Pressure in Healthy Subjects (PIO-WDT)

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.
 
ClinicalTrials.gov Identifier: NCT02843971
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Monocentric, prospective study, comparison of the water drinking test response in the supine and in the sitting position using the intraocular pressure monitoring device Sensimed Triggerfish in healthy subjects.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Device: Intraocular pressure measurement with the Sensimed triggerfish Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Intraocular Pressure Measurement Device Sensimed Triggerfish in Healthy Subjects
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Healthy volunteers Device: Intraocular pressure measurement with the Sensimed triggerfish Device



Primary Outcome Measures :
  1. Measure of intraocular pressure while lying down [ Time Frame: 30 minutes ]

    Peak IOP defined by the maximum level reached Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the sensimed triggerfish device.

    On one eye and the lens is inserted on the other eye.


  2. Measure of intraocular pressure while sitting [ Time Frame: 30 minutes ]

    Peak IOP defined by the maximum level reached; Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the sensimed triggerfish device.

    On one eye and the lens is inserted on the other eye.


  3. Measure of intraocular pressure on the eye without the lens. [ Time Frame: 30 minutes ]
    Peak IOP defined by the maximum level reached; Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the non-contact tonometer.

  4. Mesure of intraocular pressure on the eye [ Time Frame: One hour and a half ]
    Six results. Without the lens each 15 minutes. After drinking 1 L of water.

  5. Mesure of intraocular pressure on the eye without the lens each 30 minutes. [ Time Frame: One hour ]
    Two results. After drinking 1 L of water.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Aged over 18 years
  • No previous ophthalmic conditions
  • Spherical equivalent from - 6 to +3 diopters

Exclusion Criteria:

  • Contact lens use

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 ClinicalTrials.gov identifier (NCT number): NCT02843971


Locations
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France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Florent APTEL, MD, PhD Department of Ophthalmology CHU de Grenoble/University Hospital of Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02843971    
Other Study ID Numbers: 38RC14.317
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Grenoble:
Water Drinking Test
Intraocular Pressure
Sensimed Triggerfish