Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

NCT ID: NCT01123343

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

Subjects Undergoing Cataract Surgery and Insertion of IOL

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TrueVision 3D Visualization and Guidance System for MicroSurgery

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

TrueVision 3D Visualization and Guidance System for MicroSurgery

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TrueVision Systems, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Packer, MD

Role: STUDY_DIRECTOR

Oregon Eye Associates

Robert Weinstock, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Institute of West Florida

Jason Stahl, MD

Role: PRINCIPAL_INVESTIGATOR

Durrie Vision

Douglas Katsev, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Clinic

Locations

Drs. Fine, Hoffman and Packer

Eugene, Oregon, United States

Countries

United States

Other Identifiers

TVS-2009-001

Identifier Type: -

Identifier Source: org_study_id