Feasibility investigation of biometry measurements with new device features (Fresnel topography technique)

Not Applicable

• Conditions: Collection of device raw and data from subjects with different lens stages (natural, artificial) and individual structural features

• Registration Number: DRKS00019894
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-30
• Study Completion: 2020-12-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 87

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
no secondary endpoint is foreseen