Clinical trial NCT01550939: Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pseudoaphakia
Keywords: Biometry of the Eye
Intraocular Lens Implantation
IOL
Lead sponsor: Haag Streit USA
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Subjects wbo meet all of the following criteria are eligible to participate in tbe study:

1. Male or female l8 years of age or older on the date of Informed Consent.
2. At least one eye of each subject must be a phakic eye.
3. Subject must be able to fixate on a target.
4. Able to understand and willing to sign tbe informed consent.

Exclusion Criteria:

Subjects will be excluded from the study if the following applies:

1. History of corneal surgery.
2. Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
3. Any ophthalmic condition preventing use of either of the instruments used in the study.
4. Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
5. Any medical condition, which, in tbe Investigator's judgment, interferes with the subjects ability to comply with tbe protocol, compromises subject safety, or interferes with tbe interpretation of the study results.

Primary outcomes:
measure: Time to complete a full examination
timeFrame: At Study Visit (study consists of 1 visit only)
Secondary outcomes:
measure: Data Entry Time Measurement
timeFrame: At Study Visit (study consists of 1 visit only)
measure: Measurement Acquisition Time Measurement
timeFrame: At Study Visit (study consists of 1 visit only)
measure: Adverse Events
timeFrame: Duration of study from signing informed consent to Study Visit (study consists of 1 visit only)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
Study officials:
affiliation: Cincinnati Eye Institute
name: Michael E. Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References: