The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Corneal haze/scarring
研究概览
简要总结
Corneal crosslinking (Crosslinking, CXL) is a treatment offered for the stabilization of early corneal ectatic disorders such as keratoconus. Although CXL is an excellent treatment option to stabilize early ectatic corneas, complications include corneal haze, sterile infiltrate, endothelial cell toxicity, treatment failure and stromal scarring. Corneal haze is a common finding in almost all CXL patients and may decrease visual quality. The effect of 0.02% mitomycin C (MMC) for 2 minutes on corneal haze and scarring in refractive surgery is well established in the literature with many clinical studies confirming its effectiveness. Although the pattern of corneal haze after CXL appears to be different from the haze pattern seen following refractive procedures, both processes are thought to be caused by an inflammatory response.
The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study will be double blinded from the patients and the researchers. An external pharmacy will be responsible for preparing the investigational product (IP) in an open manner, which will be transferred to the research pharmacy of the CIUSSS de l'Est-de-l'Île-de-Montréal. The research pharmacy will label and dispense the IP in a blinded manner for study team on the day of treatment and according to the randomization list provided by the study team.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
- •Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.
排除标准
- •Patients who are pregnant
- •Patients who are breast-feeding
- •Patients who have allergy to MMC
- •Patients with other corneal conditions such as limbal stem cell deficiency (LSCD)
- •Patients with peripheral marginal keratitis
- •Patients with history of corneal melting
- •Patients with history of HSV/VZV keratitis
- •Patients with history of hydrops
研究组 & 干预措施
CXL with MMC
Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC).
干预措施: Application of 0.02% MMC over 60 seconds post corneal crosslinking. (Drug)
CXL without MMC
Patients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC).
干预措施: Corneal crosslinking without the application of 0.02% MMC (Drug)
结局指标
主要结局
Corneal haze/scarring
时间窗: 18 months post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
次要结局
- Glare(1 month, 3 months, 6 months, 12 months and 18 months post-operation.)
- Higher-order aberrations(1 month, 3 months, 6 months, 12 months and 18 months post-operation.)
- Clinical haze grade(1 month, 3 months, 6 months, 12 months and 18 months post-operation.)