Femtosecond Laser-Assisted Keratoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Surgical outcomes
研究概览
简要总结
The purpose of this study will be to determine optimal surgical technique for performing FLAK including laser parameters, keratoplasty shape and suture technique in order to standardize surgical technique and to collect safety and efficacy data. This will be compared to data of patients with full thickness PKP to measure visual outcomes, refraction, astigmatism, surgical methods and wound healing.
详细描述
FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser, but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range. There is minimal postoperative inflammation and collateral tissue damage.
Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on clinical findings. Subjects will be enrolled regardless of race or gender on a first come first serve basis. Subjects will be recruited from the physicians own clinic.
PKP Subjects: We will do a retrospective chart review on subjects who have undergone traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual outcomes, wound healing and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corneal opacification.
- •Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.
- •Ability to participate in follow-up visits..
排除标准
- •Corneal opacification adequately dense to obscure visualization of iris.
- •ETDRS-measured, best-corrected, distance visual acuity of 20/30 or better.
- •Corneal thickness greater than 1200 µm at the 9 mm peripheral zone.
- •Severe corneal thinning including descemetocoele with impending corneal rupture.
- •Prior PKP or incisional surgery that may provide a potential space into which the gas produced by the procedure can escape.
- •Poor visual potential in the non-study eye (VA of 20/100 or less, without potential for improvement by the examining ophthalmologist's judgment).
- •History of glaucoma, including steroid response rise in intraocular pressure.
- •Active intraocular inflammation or infection.
- •Age 18 or younger (consideration will be given to an upper age limit).
- •Unable to return for scheduled follow-up examinations.
- •Other medical condition(s) that will likely prevent long term follow-up.
结局指标
主要结局
Surgical outcomes
时间窗: 1 day, 1 week, 1, 3, 6, 12, 18 and 24 months
Wound healing, surgical complications, visual function and endothelial layer assessment
次要结局
未报告次要终点
研究者
Shahzad Mian
Professor, Department of Ophthalmology
University of Michigan