Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Increase of visual acuity
研究概览
简要总结
LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.
Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)
详细描述
The main problem at young patients post - LASIK after one year is residual refractive errors.
The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).
The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.
The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •residual hypermetropic refraction,
- •low visual acuity
排除标准
- •active anterior segment pathology,
- •glaucoma,
- •retinae detachment,
研究组 & 干预措施
Treatment of residual hypermetropia refraction after LASIK
The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D).
The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.
干预措施: ReLex Smile (Device)
结局指标
主要结局
Increase of visual acuity
时间窗: 12 months
Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.
次要结局
未报告次要终点
研究者
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo