Pseudoaphakia Clinical Trial
Official title:
A Single-Center, Open-Label, Randomized Clinical Study Measuring Time Needed for Testing Between the Haag-Streit Lenstar 900 Version i4 and the Carl Zeiss IOL Master 500 Instruments
The objectives of this study are to determine the time needed to complete a full set of measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement) by each test device, the Lenstar 900 Version i4 and IOL Master 500.
This is an open-label study randomized by sequence. Each eligible subject who signs a consent
form and fulfills all Inclusion/Exclusion criteria will undergo ophthalmic measurements by
the two test products:
A. Haag-Streit Lenstar Version i4
B. Zeiss IOL Master 500
The order of measurements for the IOL Master 500 and the Haag-Streit Lenstar Version i4 will
he randomized. The two possible sequences will be balanced (approximately 22 eyes each:
AB,BA). One eye of each subject will be measured. Time needed to complete testing will be
measured utilizing a stop-watch. Total time needed to complete all measurements of the study
eye using each of the test products to capture a complete ophthalmic exam with the devices
standard operating settings set to automatic measurement and analysis will be calculated by
the following start and stop points:
First Timed Measurement: Measurement Acquisition Start: When the technician starts to acquire
tbe first measurement Stop: When the technician has completed all measurements
Second Timed Measurement: Subject Data Entry Start: When the technician starts to enter the
subject data. Stop: When the technician has completed subject data entry.
Third Timed Measurement: Complete Ophthalmic Exam with each test product Start: When tbe
subject is seated at the instrument, just prior to the technician entering any subject data
into the test product.
Stop: Upon completion of all measurements using one of the test products, just prior to
printing results.
Three trained technicians will operate tbe same study devices (Haag-Streit Lenstar Version i4
and IOL Master 500). Approximately equal number of subjects will be assigned to each
technician.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04224129 -
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| Completed |
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N/A |