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

NCT02843971 | Completed

• 1 other identifier: 38RC14.317
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Keywords

Water Drinking Test; Intraocular Pressure; Sensimed Triggerfish

Outcome Measures

Primary Outcomes (5)

• Measure of intraocular pressure while lying down

  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

  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.

  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

  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.

  Two results. After drinking 1 L of water.

  One hour

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Device: Intraocular pressure measurement with the Sensimed triggerfish Device

Interventions

Intraocular pressure measurement with the Sensimed triggerfish Device DEVICE

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contact lens use

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38043, France

Location

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MeSH Terms

Interventions

Tonometry, Ocular

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Florent APTEL, MD, PhD

  Department of Ophthalmology CHU de Grenoble/University Hospital of Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: July 26, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 26, 2016

Record last verified: 2016-06

Locations

FR (1)