NCT01713660已完成不适用
A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
研究概览
简要总结
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 21 years of age
- •Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
- •Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
- •Clear intraocular media other than cataract
- •Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
- •Signed informed consent
排除标准
- •Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
- •History of active or recurrent ophthalmic disease
- •Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
- •White to white measurement less than 10 mm or greater than 14 mm
- •Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
- •Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
- •Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
- •Subjects with conditions associated with increased risk of IOL/capsule instability
- •Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities
- •Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)
- •History of any ocular or medical conditions that could affect corneal wound healing
- •Poorly-controlled diabetes or subjects with diabetic retinopathy
- •Concurrent use of topical or systemic medications that may impair corneal wound healing
- •Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
- •Ocular hypertension (> 21 mm Hg)
- •Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course
- •Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit
结局指标
主要结局
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
时间窗: Day 0, Operative (Within 2 hours of incision creation)
Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).
次要结局
- Surgeon Assessment of Workflow(Day 0, Operative)
- Percent of Seidel Staining(Day 0 (performed immediately post-incision creation), Day 1)
研究者
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终止
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