Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01123343

Enrollment

Registered

2010-05-14

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects Undergoing Cataract Surgery and Insertion of IOL

Keywords

limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization

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.

Interventions

DEVICETrueVision 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures	one month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026