NCT01241279终止4 期
A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Amplitude of Accommodation
研究概览
简要总结
The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have clear intraocular media other than cataract.
- •Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
- •Subjects must be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
- •Subjects must require a spherical lens power from 10.00 D to 30.00 D.
- •Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
- •Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.
排除标准
- •Subjects with corneal pathology potentially affecting topography.
- •Subjects whose fundus cannot be assessed preoperatively.
- •Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
- •Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
- •Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
- •Subjects with uncontrolled glaucoma.
- •Subjects with previous retinal detachment.
- •Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/30 or worse.
- •Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
- •Subjects with marked microphthalmos or aniridia.
- •Subjects who have had previous corneal surgery.
- •Subjects with irregular corneal astigmatism.
- •Subjects with amblyopia which reduces potential acuity to worse than 20/
- •Subjects with optic atrophy.
- •Subjects with iris neovascularization.
- •Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
- •Subjects with chronic use of systemic steroids or immunosuppressive medications.
- •Subjects lacking intact binocular vision.
结局指标
主要结局
Amplitude of Accommodation
时间窗: Visit 4 (postoperative day 120-180)
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
次要结局
- Visual Acuity(All visits through visit 4 (day 160-180))
研究者
研究点 (2)
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