Pilot Study of Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective refraction
研究概览
简要总结
This pilot study will compare upto 15 patients undergoing femtolaser assisted keratoplasty (using CE[Conformité Européene] approved femtolaser apparatus) with upto 15 patients undergoing conventional keratoplasty with a manual trephine. Patients will be randomly assigned to either group. All keratoplasties will be penetrating keratoplasties. The following aims of this research is detailed below:
- Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA (Best Corrected Visual Acuity)?
- Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence?
- Is there any difference between FLAK and conventional keratoplasty in terms of graft failure or rejection?
Follow up in best corrected visual acuity, various refraction/astigmatism measurements, intraocular pressure, graft rejection/failure rates, pachymetry and corneal hysteresis and resistance factor will be recorded at 1 day, 1 week, 1, 3 and 6 months and 1 year and 18 months postoperatively.
This study, to the investigators' knowledge will be the first randomised controlled trial in this area, the first to provide an empirical measurement to biomechanical stability of the cornea with the femtolaser, and the first done in an NHS (National Health Service) setting.
详细描述
Introduction The femtosecond laser has had a profound effect on refractive surgery and, more recently, on cataract surgery and cornea transplantation. The superior precision and control offered by femtosecond laser and its potential use in cornea transplantation show promise in terms of wound stability and strength.
By doing this research project the investigators aim to answer the following questions:
- Does femtosecond laser assisted keratoplasty ( FLAK ) yield faster visual recovery and better long term BCVA?
- Does FLAK offer a biomechanically stronger cornea and thereby more safety and less risk of wound dehiscence?
- Is there any difference between FLAK and conventional keratoplasty in terms of graft failure or rejection?
There have been other studies that have compared femtolaser to the manual trephine in corneal transplant keratoplasty surgery. The investigators' study, to their knowledge, will be the first randomised controlled trial in this area. The majority of interventional studies comparing the two procedures are retrospective case controls. This study, will also be the first to provide an empirical measurement to the biomechanical stability of corneas that have undergone femtolaser corneal transplant. Although theorised to be better with the femtolaser, there has yet to have been a comparative study that has utilised quantitative evidence supporting this. By measuring postoperative corneal hysteresis and corneal resistance factor using an ocular response analyser, the investigators hope to be able to do that.
Recruitment, inclusion/exclusion and method Patients attending the cornea firm at the eye unit in University Hospitals Southampton who are indicated for penetrating keratoplasty as a result of corneal disease or pathology will be recruited. The participants have no connection to the university or the researcher that is known before the research starts. The aim for this study is to have a minimum of 10 patients recruited altogether and a maximum of 30.
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
盲法说明
No masking as the investigators are assessing differences in surgical technique
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes with corneal opacities owing to previous corneal pathology.
排除标准
- •Eyes with concomitant ocular pathology which may affect visual acuity.
- •Eyes who received previous corneal grafts.
结局指标
主要结局
Subjective refraction
时间窗: Followed up periodically for upto 18 months
A measure of refractive error
Intraocular pressure
时间窗: Followed up periodically for upto 18 months
Fluid pressure inside the eye
Best Corrected Visual Acuity
时间窗: Followed up periodically for upto 18 months
Measure of clarity of vision
Corneal hysteresis
时间窗: Followed up once at 3 months
Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)
Corneal topography
时间窗: Followed up periodically for upto 18 months
A visual outcome measure assessing corneal curvature. Will be done using a pentacam.
Endothelial cell density
时间窗: Followed up periodically for upto 18 months
A measure of healing in the new graft
Corneal Resistance Factor
时间窗: Followed up once at 3 months
Measure of biomechanical stability of the cornea. Will be done by one machine (Ocular Response Analyser)
Keratometry
时间窗: Followed up periodically for upto 18 months
A visual outcome measure assessing corneal curvature. Will be done using a pentacam.
Pachymetry
时间窗: Followed up periodically for upto 18 months
A visual outcome measure assessing corneal thickness. Will be done using a pentacam,
Corneal irregularity index
时间窗: Followed up periodically for upto 18 months
A visual outcome measure assessing corneal curvature. Will be done using a pentacam.
Astigmatism
时间窗: Followed up periodically for upto 18 months
A visual outcome measure assessing corneal curvature. Will be done using a pentacam.
次要结局
未报告次要终点