Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Corneal transparency
研究概览
简要总结
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.
详细描述
Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.
In our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.
Stromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.
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
- 21 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low transparenc of cornea
- •low visual acuity
- •recurrence of herpetic stromal keratitis
排除标准
- •previous corneal or anterior segment surgery
- •any infection
研究组 & 干预措施
Stromal lenticule implantation for management of herpetic stromal keratitis
The thickness of the herpetic stromal scar in the cornea is calculated in microns in OCT. Based on that extraction is performed using SMILE, a new lenticular stromal pocket is placed in the same volume. AS-OCT evaluated the corneal topography, glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were monitored during the follow-up period.
During the three year follow-up period, no signs of recurrence or infections were detected in this patient.
干预措施: Relex-Smile (Other)
结局指标
主要结局
Corneal transparency
时间窗: 12 months
Implantation of corneal stromal lenticules with stromal stem cells, live keratocytes and telocytes, stromal haze and scar have been successfully treated and stabilized the biomechanical stability of cornea in 87% of the patients which underwent this treatment.
次要结局
- Evaluation of visual acuity(12 months)
研究者
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo