Skip to main content
OpenTrials
Completed

NCT Number: NCT01123343

Clinical Evaluation of TrueVision System: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subjects Undergoing Cataract Surgery and Insertion of IOL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Drs. Fine, Hoffman and Packer

Eugene, Oregon, 97401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrueVision 3D Visualization and Guidance System for MicroSurgery

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

Primary outcomes

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

    Time frame: one month

Sponsors and collaborators

Lead sponsor

TrueVision Systems, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 14, 2010
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.