Collection of device raw and data from subjects with different lens stages (natural, artificial) and individual structural features
Conditions
Interventions
Group 1: Application of Clinical Prototype, application of IOLMaster 700
Sponsors
Carl Zeiss Meditec AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Able and willing to make the required study visit; - Able and willing to provide consent and follow study instructions; - Patients must have read, understood and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Eye drops (tear fluid substitutes) used prior to the measurement (at least 2 hours without eye drops; except mydriatic agents for pupil dilatation). 2. Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement. 3. Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, etc.). 4. Permanent insufficient eyelid opening or eyelashes, which partially conceal alignment or keratometry reflections, inhibiting valid measurements (i.e. typical keratometry measurements with 3-4 mm zone should be ensured). 5. Rigid contact lenses wearing within one day prior to the measurement (if worn, lenses should be removed at least one day prior to the measurements). 6. Soft contact lenses wearing within one day prior to the measurement (if worn, lenses should be removed at least one day prior to the measurements). 7. Principal Investigator’s determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF). 8. Known Pregnancy. 9. Patients who are participating in another ophthalmological clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this investigation is to use the device data from a heterogeneous patient population to develop the algorithm for the biometry (e.g. topography and keratometry) measurements. Device data will be acquired during the investigational measurement visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| no secondary endpoint is foreseen | — |
Countries
Austria
Contacts
Public ContactClaudia Kirbs
Carl Zeiss Meditec AG
Outcome results
None listed