CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- TrueVision Systems, Inc
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
LRI 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 compared to the current standard of care (manual markings or heuristic techniques) for LRI.
Intervention: TrueVision 3D Visualization and Guidance System for MicroSurgery (Device)
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 compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis.
Intervention: TrueVision 3D Visualization and Guidance System for MicroSurgery (Device)
Outcomes
Primary Outcomes
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Time Frame: one month
Secondary Outcomes
No secondary outcomes reported