Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

TrueVision Systems, Inc35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Subjects Undergoing Cataract Surgery and Insertion of IOL

Interventions

TrueVision 3D Visualization and Guidance System for MicroSurgeryDEVICE

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Drs. Fine, Hoffman and Packer

Eugene, Oregon, United States

Outcomes

Primary Outcomes

Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures

Time frame: one month

Data from ClinicalTrials.gov

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