Time Study for Biometry Measurements With the Lenstar and IntraOcularLens (IOL) Master 500

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haag Streit USA
ClinicalTrials.gov Identifier:
NCT01550939
First received: March 5, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pseudoaphakia
Device: Ophthalmic Biometer
Phase 4

Study Type: Interventional
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

Further study details as provided by Haag Streit USA:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 61
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Time Comparison between the Lenstar and IOLMaster Device: Ophthalmic Biometer
One complete biometry examination
Other Names:
  • Haag-Streit Lenstar
  • Zeiss 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550939

Locations
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Haag Streit USA
Investigators
Principal Investigator: Michael E. Snyder, MD Cincinnati Eye Institute
  More Information

No publications provided

Responsible Party: Haag Streit USA
ClinicalTrials.gov Identifier: NCT01550939     History of Changes
Other Study ID Numbers: HS1 Time Study 2
Study First Received: March 5, 2012
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Haag Streit USA:
Biometry of the Eye
Intraocular Lens Implantation
IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014