Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
研究概览
简要总结
To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).
详细描述
10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ask for PRK surgery
- •Patients with stable refraction in the last year
- •Patients without systemic and ocular disease
- •Patients with 500 microns in pachymetry normal topography
排除标准
- •Patients cannot attend their appointments
- •Residual, recurrent or active ocular disease
- •Previous ocular surgery except PRK
- •Autoimmune or connective tissue disease
- •Pregnancy
研究组 & 干预措施
1
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
干预措施: Mitomycin C and Photorefractive keratectomy (PRK) (Drug)
2
Photorefractive keratectomy (PRK)without mitomycin C.
干预措施: Mitomycin C and Photorefractive keratectomy (PRK) (Drug)
结局指标
主要结局
A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
时间窗: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery
次要结局
未报告次要终点