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Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

NCT01123343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-06-29

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • TrueVision Systems, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Packer, MD · Oregon Eye Associates

  • Robert Weinstock, MD · Eye Institute of West Florida

  • Jason Stahl, MD · Durrie Vision

  • Douglas Katsev, MD · Sansum Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123343 on ClinicalTrials.gov