Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma and ocular hypertension patients
Brief summary
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.
Interventions
DEVICESENSIMED Triggerfish
2-hour continuous IOP monitoring
Sponsors
Clinique de Montchoisi, Lausanne, Switzerland
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of glaucoma or ocular hypertension * IOP of ≥ 15 mmHg. * Patients of either gender. * Older than 18 years. * Patients who accept signing an informed consent approved by the Ethics Committee.
Exclusion criteria
* Patients not able to understand the nature of the research * Patients under tutorship * Corneal abnormalities in both eyes * Subjects with contraindications for wearing contact lenses * History of ocular surgery within the last 3 months * Known hypersensitivity to Diamox® or to any of its excipients * Pregnancy and lactation * Simultaneous participation in other clinical research * Patients with evidence of ocular infection or inflammation * History of renal or hepatic impairment, hypokalemia and hyponatremia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of IOP reduction 2 hours after Diamox administration | 2 hours |
Countries
Switzerland
Outcome results
None listed