ACTRN12611000443998已完成未知
Evaluation of the LenSx Laser System for Performing Anterior Capsulotomy, Phacofragmentation, and Corneal Arc Cuts/Incisions in Patients Undergoing Cataract Surgery for Removal of the Crystalline Lens
Vision Eye Institute Chatswood0 个研究点目标入组 40 人开始时间: 2011年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 24 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1.Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
- •2.Subjects must be willing and able to return for scheduled follow-up examinations.
- •3.Subjects must sign and be given a copy of the written Informed Consent form.
排除标准
- •1.Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- •2.Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- •3.Subjects with known sensitivity to planned study concomitant medications.
- •4.Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- •5.Subjects presenting any contraindications to cataract surgery.
- •6.Hypotony, glaucoma, or the presence of a corneal implant.
- •7.Presence of blood or other material in the anterior chamber.
- •8.Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease).
- •9.A history of lens or zonular instability.
- •Exclusion For Laser Group Only
- •10.Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength.
- •11.Corneal opacity that would interfere with the laser beam.
- •12.Descemetocele with impending corneal rupture.
- •13.Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy.
- •14.Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only).
- •15.Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape.
- •16.Corneal thickness requirements that are beyond the range of the system (>1500 microns).
研究者
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