Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

June 25, 2015 updated by: TrueVision Systems, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Drs. Fine, Hoffman and Packer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVS-2009-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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