Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •Narrow or closed iridocorneal angle
Outcomes
Primary Outcomes
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
Time Frame: 30-45 min after WDT
Secondary Outcomes
No secondary outcomes reported