Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

• Sponsor: Sensimed AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01362868
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Device: SENSIMED Triggerfish®	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Outcome Measures

Primary Outcome Measures

1. SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT [30-45 min after WDT]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unité de Glaucome, Clinique de Montchoisi	Lausanne		Switzerland	1006

Sponsors and Collaborators

• Sensimed AG

Investigators

• Principal Investigator: André Mermoud, MD, Clinique de Montchoisi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01362868
• Other Study ID Numbers: 1012
• First Posted: May 30, 2011
• Last Update Posted: Nov 9, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by , ,: Glaucoma; Triggerfish; Water drinking test

Study Results

No Results Posted as of Nov 9, 2011