NCT00413881已完成不适用
A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 1.Safety 2. Efficacy 3. Refractive stability
研究概览
简要总结
The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.
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
- 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
- •Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- •At least 6 months from original LASIK surgery.
- •Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction.
- •Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test.
- •The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap.
- •Manifest refraction and LADARWave™ refractions must be within 1.00D.
- •At least 3 lines potential improvement in UCVA.
- •BSCVA of 20/20 or better.
- •Good corneal flap and interface.
- •Adequate corneal thickness for surgery (residual stromal bed > 280 microns).
- •Able and willing to give informed consent.
- •Located in the greater Washington DC area for a 12-month period.
- •Access to transportation to meet follow-up requirements.
排除标准
- •Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Pregnancy will be ruled out with a urine pregnancy test.
- •Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history.
- •Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history).
- •Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- •Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.
- •Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- •Flap irregularity(striae, interface debris, scarring, or epithelium).
- •Calculated residual stroma bed less than
- •Stable refraction with less than 0.75D of spherical equivalent from the desired correction and more than 1.5D of cylinder in the manifest refraction.
结局指标
主要结局
1.Safety 2. Efficacy 3. Refractive stability
时间窗: one year after enhancement
次要结局
未报告次要终点
研究者
研究点 (2)
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