Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TrueVision Systems, Inc
ClinicalTrials.gov Identifier:
NCT01123343
First received: May 12, 2010
Last updated: June 25, 2015
Last verified: June 2015

May 12, 2010
June 25, 2015
January 2010
June 2010   (final data collection date for primary outcome measure)
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01123343 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates
CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES

To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Subjects Undergoing Cataract Surgery and Insertion of IOL
Device: TrueVision 3D Visualization and Guidance System for MicroSurgery
Adjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram
  • Active Comparator: LRI Templates
    To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for LRI.
    Intervention: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery
  • Active Comparator: Capsulorhexis Templates
    To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis.
    Intervention: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy eye with no previous ocular surgery
  • Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
  • Clear intraocular media other than cataract
  • Potential visual acuity 20/30 or better
  • Able to comply with preop and postop examination procedures
  • Signed and dated informed consent

Exclusion Criteria:

  • Keratometric astigmatism > 2.5 diopters
  • Corneal pathology potentially affecting topography including corneal degeneration
  • Irregular astigmatism
  • Macular degeneration or any other macular disease which reduces potential acuity
  • Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
  • Use of systemic or ocular medications that affects vision
  • Acute or chronic systemic or ocular disease or illness that would increase risk or confound study results
  • Use of Flomax or any other medication which negatively impacts surgical outcomes
  • History of ocular trauma or ocular surgery
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01123343
TVS-2009-001
No
TrueVision Systems, Inc
TrueVision Systems, Inc
Not Provided
Study Director: Mark Packer, MD Oregon Eye Associates
Principal Investigator: Robert Weinstock, MD Eye Institute of West Florida
Principal Investigator: Jason Stahl, MD Durrie Vision
Principal Investigator: Douglas Katsev, MD Sansum Clinic
TrueVision Systems, Inc
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP