A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Reduction of Astigmatism
研究概览
简要总结
To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.
详细描述
Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.
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
- •1. Male or female, of any race, and at least 21 years of age at the time of pre-op exam
- •2. Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
- •3. Best Spectacle Corrected Distance Visual Acuity (BSCVA)
- •1. Group 1:
- •* Natural astigmatism, no cataract - BSCVA of 20/25 or better
- •* Pre cataract or phakic IOL surgery - no BSCVA criteria
- •2. Group 2:
- •* Post IOL surgery- BSCVA of 20/25 or better
- •4. Uncorrected Visual Acuity (UCVA) of 20/40 or worse
- •5. Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within \ 1.5 D.
- •6. Preoperative central pachymetry of \>/=480 um
- •7. Keratometry between 38.0 D (flat) to 48.0 D (steep)
- •8. Corneal power (diopters) difference at the 3mm point from topographic center shall be \
排除标准
- •Angle kappa of greater than 0.5 mm, absolute value
- •Prior implantation of toric or multifocal intraocular lens
- •Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- •Concurrent use of topical or systemic medications that may impair corneal wound healing
- •History of any ocular or medical conditions that could affect corneal wound healing
- •History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye
- •Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye
- •Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
- •Participation in any other conflicting clinical study
研究组 & 干预措施
Natural Astigmatism
Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
干预措施: iFS Femtosecond Laser System (Device)
Post Cataract with Residual Astigmatism
Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
干预措施: iFS Femtosecond Laser System (Device)
结局指标
主要结局
Reduction of Astigmatism
时间窗: 6 months
Reduction of astigmatism as determined by manifest refractive cylinder
次要结局
- Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)(6 months)