A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 12
- 主要终点
- Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
研究概览
简要总结
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.
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
- None
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
- •Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
- •Adults between the ages of 40 and 80 inclusive.
- •Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
- •Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
- •Clear intraocular media other than cataract.
- •Potentially good vision in the fellow eye with BCVA 20/40 or better.
- •Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
- •Fully dilated pupil diameter of more than or equal to 7.0 mm.
排除标准
- •Zonular laxity or dehiscence.
- •Pseudoexfoliation.
- •Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
- •Retinal degenerative disorder that is expected to cause future vision loss.
- •Diabetes with any evidence of retinopathy.
- •Evidence of glaucomatous optic neuropathy.
- •History of uveitis.
- •Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
- •Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
- •Keratoconus or suspected of having keratoconus.
- •Corneal dystrophy including basement membrane dystrophy.
- •Previous corneal or intraocular surgery
- •Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
- •Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.
研究组 & 干预措施
Lens implantation +1.00 diopter (D) postop target
Lens implant power calculated for postoperative MRSE target of +1.00 D
干预措施: Lens implantation +1.00 D postop target (Device)
Lens implantation -1.00 D postop target
Lens implant power calculated for postoperative MRSE target of -1.00 D
干预措施: Lens implantation -1.00 D postop target (Device)
Lens implantation 0.00 D postop target
Lens implant power calculated for postoperative MRSE target of 0.00 D
干预措施: Lens implantation 0.00 D postop target (Device)
结局指标
主要结局
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
时间窗: 6 months post-operative
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
次要结局
- Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)(6 months post operative)