Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Detailed Description

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32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). 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. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.

After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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SENSIMED Triggerfish®

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer without previous ocular medical history
* 18 years or more at inclusion
* Maximal weight: 100kg
* BMI lower or equal to 30 kg/m2
* Subjects having provided informed consent

Exclusion Criteria

* Silicone allergy
* Cardiovascular disease
* Diabetes
* Narrow or closed iridocorneal angle

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Clinique de Montchoisi

Principal Investigators

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André Mermoud, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique de Montchoisi

Locations

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Unité de Glaucome, Clinique de Montchoisi

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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1012

Identifier Type: -

Identifier Source: org_study_id