Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Mean endothelial cell loss
研究概览
简要总结
The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities
详细描述
Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.
Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.
All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.
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
- 18 Years 至 52 Years（Adult）
- 接受健康志愿者
- 否
入选标准
- •Advanced keratoconus or stromal corneal scattering
- •Normal endothelial cell density
排除标准
- •Acute keratoconus in the anamnesis
- •Low endothelial cell density
- •Age under 18 years
结局指标
主要结局
Mean endothelial cell loss
时间窗: 12 months after surgery
BSCVA (best spectacle-corrected visual acuity)
时间窗: 12 months after surgery
Mean postoperative astigmatism
时间窗: 12 months after surgery
UCVA (uncorrected visual acuity)
时间窗: 12 months after surgery
次要结局
- Corneal resistance factor(12 months after surgery)
- Central corneal thickness(12 months after surgery)
- Corneal hysteresis(12 months after surgery)
- Residual recipient's tissue thickness(12 months after surgery)
研究者
Alexey Pashtaev
Alexey Pashtaev MD, PhD
The S.N. Fyodorov Eye Microsurgery State Institution