H40.1 H26.8
Conditions
Interventions
Group 1: An active telemetric intraocular pressure sensor will be implanted in one eye of the study subjects
Sponsors
ImplanData Ophthalmic Products GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: primary open-angle glaucoma, cataract, intraocualr pressure under control, age 18-80 years, informed consent, understanding of the study purpose and study design, signed informed consent
Exclusion criteria
Exclusion criteria: sekundary glaucoma, diseases of the cornea, diabetic retinoapthy, uveitis, retinal detechment, intraocular surgery < 6 month, intraocular pressure out of control, axial length <22mm, missing comprehension of the study, severe life-limiting diseases, psychiatric diseases, prgnancy, participance in an other clinical study, other active medical implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month control: determination of the safety of the implantation of the telemtric intraocular pressure sensor in the human eye. Safety measurements are performed at each visit using ophthalmological non-invasive diagnostics (slitlamp, intraocular pressure, visual fields, cornea examinations, macula structure, visual acuity and refraction. Adverse events will be surveyed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the precision and reproducibility of the telemtric intraocular pressure measurement with an implanted pressure sensor in humans, comparison of intraocular pressure values with a reference tonometer and evaluation of self-tonometry. (Visit month 1-6 and visit month 7-12) | — |
Countries
Germany
Contacts
Public ContactNiklas Plange
Augenklinik des UKAachen
Outcome results
None listed