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
  Purpose

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.


Condition Intervention Phase
Subjects Undergoing Cataract Surgery and Insertion of IOL
Device: TrueVision 3D Visualization and Guidance System for MicroSurgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES

Resource links provided by NLM:


Further study details as provided by TrueVision Systems, Inc:

Primary Outcome Measures:
  • Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01123343

Locations
United States, Oregon
Drs. Fine, Hoffman and Packer
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
TrueVision Systems, Inc
Investigators
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
  More Information

No publications provided

Responsible Party: TrueVision Systems, Inc
ClinicalTrials.gov Identifier: NCT01123343     History of Changes
Other Study ID Numbers: TVS-2009-001
Study First Received: May 12, 2010
Last Updated: June 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by TrueVision Systems, Inc:
limbal relaxing incision
LRI
capsulorhexis
surgical guidance
3d visualization

ClinicalTrials.gov processed this record on July 05, 2015