Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- Time to complete a full examination [ Time Frame: At Study Visit (study consists of 1 visit only) ] [ Designated as safety issue: No ]Time to complete a full ophthalmic exam(as measured from the time of subject placement just prior to the technician completing data entry at the test product, to the beginning of data printing) for each, the IOL Master 500 and the Haag-Streit Lenstar Version i4.
- Data Entry Time Measurement [ Time Frame: At Study Visit (study consists of 1 visit only) ] [ Designated as safety issue: No ]Additional Time Measurements - Data Entry from the IOL Master 500 and the Haag-Streit Lenstar Version i4.
- Measurement Acquisition Time Measurement [ Time Frame: At Study Visit (study consists of 1 visit only) ] [ Designated as safety issue: No ]Additional Timed Measurements - Measurement Acquisition from the IOL Master 500 and the Haag-Streit Lenstar Version i4.
- Adverse Events [ Time Frame: Duration of study from signing informed consent to Study Visit (study consists of 1 visit only) ] [ Designated as safety issue: Yes ]Any adverse events associated with the test products
|Study Start Date:||January 2012|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|No Intervention: Time Comparison between the Lenstar and IOLMaster||
Device: Ophthalmic Biometer
One complete biometry examination
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.