Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500
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
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedAugust 1, 2012
July 1, 2012
2 months
March 5, 2012
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to complete a full examination
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.
At Study Visit (study consists of 1 visit only)
Secondary Outcomes (3)
Data Entry Time Measurement
At Study Visit (study consists of 1 visit only)
Measurement Acquisition Time Measurement
At Study Visit (study consists of 1 visit only)
Adverse Events
Duration of study from signing informed consent to Study Visit (study consists of 1 visit only)
Study Arms (1)
Time Comparison between the Lenstar and IOLMaster
NO INTERVENTIONInterventions
One complete biometry examination
Eligibility Criteria
You may qualify if:
- Subjects wbo meet all of the following criteria are eligible to participate in tbe study:
- Male or female l8 years of age or older on the date of Informed Consent.
- At least one eye of each subject must be a phakic eye.
- Subject must be able to fixate on a target.
- Able to understand and willing to sign tbe informed consent.
You may not qualify if:
- Subjects will be excluded from the study if the following applies:
- History of corneal surgery.
- Use of contact lenses during tbe ophthalmic exam or up to two hours prior to the exam.
- Any ophthalmic condition preventing use of either of the instruments used in the study.
- Any ophthalmic condition which might impair tbe validity of results from any of the instruments used in the study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haag Streit USAlead
Study Sites (1)
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E. Snyder, MD
Cincinnati Eye Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 12, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
August 1, 2012
Record last verified: 2012-07