To Evaluate the Safety and Effectiveness of the EnVista® One-Piece Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism on Postoperative Refraction Following Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 2
- 主要终点
- Mean Dioptric Change in Cylinder
研究概览
简要总结
The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.
详细描述
The investigational enVista Toric IOL, Model MX60T, and the currently approved Model MX60, are identical with the exception of the addition of toric optics and axis marks on the posterior optic surface for the correction of astigmatism on the Model MX60T. Both lenses have an aspheric biconvex optic with a modified C haptic monoblock, single-piece design. The design and material of both the MX60 and MX60T allow them to be folded and inserted through small incisions to minimize the possibility of surgically induced astigmatism (SIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction.
- •Subjects must require a lens power from 16.0 D to 27.0 D in the study eye.
- •Subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye.
- •Subjects must have a best corrected distance visual acuity (BCDVA) projected to be better than 20/30 after toric IOL implantation in the study eye.
- •Subjects must have predicted postoperative corneal astigmatism between 0.90D and 2.40D in the study eye, as determined by the Toric Calculator.
- •Subjects must have a minimum preoperative corneal astigmatism of 0.90 D in the study eye.
- •Subjects must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.
排除标准
- •Subjects who have had previous intraocular or corneal surgery in the study eye.
- •Subjects with any clinically significant ocular pathology which would be expected to reduce potential BCDVA to 20/30 or worse in the study eye during the course of the study.
- •Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery.
- •Subjects with associated ocular conditions which could affect the stability of the IOL in the study eye.
- •Subjects with a traumatic cataract in the study eye.
- •Subjects with uncontrolled glaucoma in the study eye.
- •Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
- •Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
- •Subjects with any ocular condition that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
- •Subjects with a difference of greater than 0.50D of corneal astigmatism as measured with the IOL Master and the topographer in the study eye using vector analysis.
- •Subjects with an anterior chamber depth <2mm in the study eye.
- •Subjects with potential BCDVA of 20/200 or worse in the fellow eye.
结局指标
主要结局
Mean Dioptric Change in Cylinder
时间窗: Baseline, Final Visit (scheduled within window: days 120-180)
Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).
Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
时间窗: Final Visit (scheduled within window: days 120-180)
Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit
时间窗: Final Visit (scheduled within window: days 120-180)
Best-corrected distance visual acuity (BCDVA) at Final Visit, expressed as logarithm of the minimum angle of resolution (logMAR). Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees
时间窗: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Forms 3 (scheduled within window: days 30-60) and final visit (scheduled within window: days 120-180).
次要结局
- Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit(Final Visit (scheduled within window: days 120-180))