Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation

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

Study Overview

• Status: Terminated
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: SENSIMED Triggerfish®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1006
    • Unité de Glaucome, Clinique de Montchoisi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT	30-45 min after WDT

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: André Mermoud, MD, Clinique de Montchoisi

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Glaucoma; Water drinking test; Triggerfish
• Other Study ID Numbers: 1012 (Registry Identifier: NNGYK)