DRKS00005051已完成未知
Evaluation of An Intra-Operative Toric Intraocular Lens Alignment System - CALZ-3001
Carl Zeiss Meditec AG - Site Munich0 个研究点目标入组 71 人开始时间: 2013年7月1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
- 71
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •Cataract, for which phacoemulsification and posterior chamber IOL implantation has been planned in the operative eye OR.
- •Clear crystalline lens, for which the subject has elected to undergo ‘refractive lens exchange’, with planned phacoemulsification and posterior chamber IOL implantation in the operative eye.
- •Patient age = 21 years.
- •Pre-operative corneal astigmatism =1.00 D
- •The subject must be able to provide written Informed Consent.
- •The subject must be able to return for the scheduled follow up examinations one week and six weeks after surgery.
- •Normal anterior and posterior segments.
- •Clear intraocular media – other than cataract.
排除标准
- •Corneal ectasia* (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
- •Peripheral corneal thinning disorders* (e.g. Mooren’s Ulcer or Terrien’s marginal degeneration)
- •Any forms of corneal pathology potentially affecting topography.
- •Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)*.
- •Subjects with diagnosed degenerative visual disorders * (for example macular degeneration or any other retinal disorders) that are predicted to cause future acuity losses.
- •Capsular/zonular lens abnormalities* that may affect post-operative IOL centration and/or tilt
- •Microphthalmia*.
- •Active ocular disease*, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch’s endothelial dystrophy).
- •Cornea dystrophy*, guttata* or oedema*.
- •Previous corneal graft/keratoplasty.
- •Pre-operative visual acuity* below +1.00 logMAR (6/60 Snellen)
- •Subjects with any systemic disease* that could increase operative risk or confound the outcome
- •Previous history of ocular inflammation.
- •Subjects using any systemic medication(s) known to cause ocular side effects which may adversely affect the subjects acuity.
- •Subjects who have only one eye with potentially good vision.
- •Pre-operative Keratoconjunctivitis Sicca*
- •Pupil dilation is not possible*
- •Patients who are pregnant or lactating or planning a pregnancy at the time of enrolment.
- •Subjects participating in a concurrent clinical trial or if they have participated in a clinical trial within the last 30 days.
- •*) Exclusion criteria, if evident in the operative eye.
研究者
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