Not provided
Not provided
Not provided
Not provided
Not provided
Too low effect on the output and low rate of responders
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish® | Device | Soft contact lens-based device for the continuous monitoring of IOP fluctuations |
| Measure | Description | Time Frame |
|---|---|---|
| SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT | 30-45 min after WDT |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| André Mermoud, MD | Clinique de Montchoisi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Glaucome, Clinique de Montchoisi | Lausanne | 1006 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided