Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

Study Overview
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Brief Summary
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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.

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

Conditions
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Subjects Undergoing Cataract Surgery and Insertion of IOL

Intervention / Treatment
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* Device: TrueVision 3D Visualization and Guidance System for MicroSurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRI Templates<br>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. | Device: TrueVision 3D Visualization and Guidance System for MicroSurgery<br>* 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<br>|
| Active Comparator: Capsulorhexis Templates<br>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. | Device: TrueVision 3D Visualization and Guidance System for MicroSurgery<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization