CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES

TrueVision Systems, Inc1 site in 1 country35 target enrollmentJanuary 2010

ConditionsSubjects Undergoing Cataract Surgery and Insertion of IOL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects Undergoing Cataract Surgery and Insertion of IOL
Sponsor: TrueVision Systems, Inc
Enrollment: 35
Locations: 1
Primary Endpoint: Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

December 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

TrueVision Systems, Inc

Responsible Party

Sponsor

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