niet van toepassing
Conditions
Interventions
None listed
Sponsors
Oogheelkunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age between 18 and 75 years old * Informed and having given informed consent * Willing and able to comply with scheduled visits and other study procedures * If wearing contact lenses, willing to replace them for glasses for the duration of the study
Exclusion criteria
Exclusion criteria: * Subjects with a history of eye disease * Subjects using eye drops (during the study). * Subjects with an Oriental/Asian lid crease, because of their narrow fornix. * Subjects who do not speak and/or write Dutch properly. * Subjects with a history of serious adverse reaction or hypersensitivity - Subjects with hay fever * Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the evaluation of the safety of the ocular coil. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are coil retention (duration), subject comfort (tolerance) and incidence of adverse effects and complications. | — |
Countries
Netherlands
Outcome results
None listed