NCT01062412终止不适用
A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines
LensAR Incorporated2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Increased objective amplitude of accommodation
研究概览
简要总结
The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects
详细描述
The objective of this study is to evaluate the feasibility of the LensAR Laser System to surgically intervene within the crystalline lens to improve vision by increasing amplitude of accommodation in patients having elected to undergo lens extraction and IOL implantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must sign and be given a copy of the written informed consent form.
- •Subjects must have elected to undergo lens extraction and IOL implantation to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
- •Cataract should not exceed LOCS III Grade
- •Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
- •Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
- •Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
- •Subject must have central 7 mm of clear cornea without vascularization
排除标准
- •Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- •Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
- •Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
- •Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
- •Subjects with macular degenerative pathology.
- •Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
- •Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- •Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
- •Subjects who cannot attain ocular dilation adequate to allow laser treatment within the minimum range based on the laser procedure to be applied.
- •Subjects with known sensitivity to planned study concomitant medications.
- •Subjects using systemic medication that is known to reduce the amplitude of accommodation (such as medication for motion sickness containing hyoscine or other antimuscarinic drugs, anticholinergic drugs, anti-psychotic drugs, tricyclic antidepressants and other drugs acting on the central nervous system).
- •Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
结局指标
主要结局
Increased objective amplitude of accommodation
时间窗: 1 month
次要结局
- Rate of adverse events(1 month)
研究者
研究点 (2)
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