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Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

Primary Purpose

Subjects Undergoing Cataract Surgery and Insertion of IOL

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TrueVision 3D Visualization and Guidance System for MicroSurgery
Sponsored by
TrueVision Systems, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjects Undergoing Cataract Surgery and Insertion of IOL focused on measuring limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Drs. Fine, Hoffman and Packer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LRI Templates

Capsulorhexis Templates

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2010
Last Updated
June 25, 2015
Sponsor
TrueVision Systems, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01123343
Brief Title
Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates
Official Title
CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TrueVision Systems, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects Undergoing Cataract Surgery and Insertion of IOL
Keywords
limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LRI Templates
Arm Type
Active Comparator
Arm 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.
Arm Title
Capsulorhexis Templates
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
TrueVision 3D Visualization and Guidance System for MicroSurgery
Intervention Description
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 Outcome Measure Information:
Title
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Packer, MD
Organizational Affiliation
Oregon Eye Associates
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Weinstock, MD
Organizational Affiliation
Eye Institute of West Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Stahl, MD
Organizational Affiliation
Durrie Vision
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Katsev, MD
Organizational Affiliation
Sansum Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drs. Fine, Hoffman and Packer
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

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