Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Change from preoperative topographical corneal astigmatism
研究概览
简要总结
A prospective comparison between standard deep anterior lamellar keratoplasty (S-DALK) performed manually using a blade (trephine) and femtosecond laser-enabled deep anterior lamellar keratoplasty (IE DALK), where incisions are performed using the femtosecond laser.
详细描述
Even though corneal transplants have been around for more than 100 years, and tools to improve their surgical technique keep getting perfected, both regular and irregular postoperative astigmatism continue to be major concerns in achieving predictable visual results. Femtosecond laser technology allows for the creation of more precise incisions with more reproducible patterns, which could lead us to believe that astigmatism management and visual results should be improved with this technology. This would be the first study to prospectively analyze standard versus femtosecond laser-enabled deep anterior lamellar keratoplasties in order to elucidate their relative advantages in the quest for a gold standard.
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
- Single (Care Provider)
盲法说明
Technologists who do the vision testing on participants are "masked" as to which "arm" the participant was randomized
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty
排除标准
- •Previous keratoplasty
- •Advanced glaucoma
- •Any other retinal or optic nerve pathology that could potentially affect visual outcome
- •Strabismus or amblyopia
- •Significant limbal stem cell deficiency (invlolving > 3 limbal clock hours)
- •Active autoimmune disease.
研究组 & 干预措施
Standard DALK
Standard (with the use of a blade) deep anterior lamellar keratoplasty (DALK), which is a partial thickness corneal transplant, which has been shown to be a safe and effective procedure.
干预措施: Standard Deep Anterior Keratoplasty (S-DALK) (Procedure)
IE-DALK (femtosecond)
Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions.
干预措施: IE-DALK (femtosecond) (Procedure)
结局指标
主要结局
Change from preoperative topographical corneal astigmatism
时间窗: preoperatively, 6, 12 and 15 months postoperatively
Corneal astigmatism is the difference (expressed in Diopter units) of refractive power between the steep and flat corneal meridians and is measured using corneal topography. Values range between 0 and 20 diopters. Lower values represent a better outcome.
次要结局
- Change from preoperative best-corrected distance visual acuity (BCVA)(preoperatively, 6, 12 and 15 months postoperatively.)
- Change from preoperative uncorrected distance visual acuity (UCVA)(preoperatively, 6, 12 and 15 months postoperatively.)
- Change from preoperative endothelial cell count(preoperatively, 6, 12 and 15 months postoperatively.)
- Big-bubble success rate(6 months postoperatively.)
- Rate of conversion to penetrating keratoplasty(6 months postoperatively.)
- Change from preoperative pachymetry(preoperatively, 6, 12 and 15 months postoperatively.)
- Change from preoperative higher-order optical aberrations(preoperatively, 6, 12 and 15 months postoperatively.)
研究者
Neera Singal
Director of Cornea and Refractive Surgery
Kensington Eye Institute