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)

July 22, 2016 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contact lens use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Device: Intraocular pressure measurement with the Sensimed triggerfish Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes
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.
30 minutes
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.
30 minutes
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.
One hour and a half
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.
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Florent APTEL, MD, PhD, Department of Ophthalmology CHU de Grenoble/University Hospital of Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC14.317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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