CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: TrueVision 3D Visualization and Guidance System for MicroSurgery (Device)
结局指标
主要结局
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
时间窗: one month
次要结局
未报告次要终点