Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

TrueVision Systems

Status and phase: Completed; Phase 1

Conditions: Subjects Undergoing Cataract Surgery and Insertion of IOL

Treatments: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01123343

TVS-2009-001

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

LRI Templates

Active Comparator group

Description:

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.

Treatment:

Device: TrueVision 3D Visualization and Guidance System for MicroSurgery

Capsulorhexis Templates

Active Comparator group

Description:

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.

Treatment:

Device: TrueVision 3D Visualization and Guidance System for MicroSurgery