A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 34
- 主要终点
- Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
研究概览
简要总结
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
- •Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
- •Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
- •Projected best spectacle corrected visual acuity of 20/20 or better
- •Clear intraocular media other than cataract
- •Potentially good vision in fellow eye
- •Fully dilated pupil of >= 7.0 mm
排除标准
- •Zonular laxity or dehiscence
- •Pseudoexfoliation
- •Age related macular degeneration
- •Retinal degenerative disorder
- •Diabetes with any evidence of retinopathy
- •Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
- •Corneal dystrophy, previous corneal or intraocular surgery
- •Complications during cataract surgery
- •Serious co-morbid conditions
- •Systemic medications that my increase UV sensitivity
- •Irregular astigmatism
研究组 & 干预措施
LAL
LAL implanted
干预措施: LAL (Light Adjustable Lens) and Light Deliver Device (LDD) (Device)
Monofocal control
Monofocal control IOL implanted
干预措施: Monofocal control IOL (Device)
结局指标
主要结局
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
时间窗: 6 months
Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.
Percent Absolute Reduction in MRSE
时间窗: 6 months
Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Percent Reduction in Manifest Cylinder
时间窗: 6 months
Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
次要结局
- Uncorrected Visual Acuity 20/20 or Better(6 months)
- Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)(6 months)
- Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)(6 months)
- Mean BSCVA(6 months)
- Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively(6 months)